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Reparex Against Grey Hair is a product that claims to “restore hair color naturally from the inside out, unlike hair dyes”.^[1]Reparex, (no date), Reparex Against Grey Hair. Available at: https://reparexshop.com/usa/reparex-against-grey-hair (Accessed: 30 January 2023 Reparex is owned by a company called BOOS Labs – established in 1991 – which makes many different cosmetic products.

Reparex Against Grey Hair doesn’t have any clinical efficacy and safety data associated with it and there are some inconsistencies in the information provided on their website (more on that below). However, let’s take a look at what mechanistic data might be available for this product (if any) and determine if it is a product that is worth your time and money.

Key Takeaways

• Branding. Reparex markets Against Gray Hair products as topically applied alternatives to commercially available hair dyes. Their branding is marketed towards both men and women. 
• What makes it unique? Reparex attempts to differentiate  itself from other hair colorant products by claiming that its product uses a unique mechanism. They state that  “Reparex removes Oxygen from oxidized colorless melanin using the enzyme g-reductase which binds with silver nitrate. This results in the restoration of melanin’s natural color”.^[2]Reparex, (no date), How does it work? Available at: https://reparexshop.com/usa/reparex-against-grey-hair (Accessed: 30 January 2023
• Clinical Support. Currently, no clinical data is available to show us the efficacy and safety of this product.
• Concerns.
  •  The major concern for this product is that there is no mechanistic, efficacy, or safety data (and the explanation they do provide doesn’t make a lot of sense). Basically, this means that we don’t know if this product actually works or whether it’s safe to use for any length of time. 
  • The websites and documents associated with this product include conflicting and sometimes incorrect information. This makes it confusing to navigate or really understand how the product works.
  • The before-and-after photos shown on the website appear to show the same photo for both the before and after shots. Also, in some  photos, it is impossible to actually tell if the after photo is of the same person as the before photo (examples below).
• Recommendations to Reparex. In order to improve their service and reassure potential customers, we would recommend that Reparex do the following:
  • Take a close look at the information they are providing to customers on their websites and correct inconsistencies and mistakes where possible.
  • Conduct long-term, pre-registered, placebo-controlled trials to determine the efficacy and safety of Reparex as a product that can reverse hair graying.
  • Be transparent with their before-and-after photos and encourage people to take multiple photos of different angles of the face so that it is possible to identify them as the same person.
  • Provide mechanistic data so we can understand exactly how Reparex works (in other words, what is the biological mechanism that their product supposedly affects?).
• Our Current Thoughts. Due to the points mentioned above, we cannot recommend Reparex as a product for reversing gray hair. The onus is on Reparex to provide clear information and clinical data to convince us that this product works.

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What is Reparex?

Reparex is a brand owned by a company called BOOS Labs that was established in 1991. They create multiple products including the Against Grey Hair product range. Reparex state that Against Grey Hair “Restores your own hair color, bringing back that natural look”.^[3]Reparex, (no date), Reparex Against Grey Hair. Available at: https://reparexshop.com/usa/reparex-against-grey-hair/ (Accessed: 29 January 2023

Reparex says that their product “is an outcome of life-long research made by a well-known biochemist and doctor Oto Sova, M.D, PhD. He developed and created a unique enzymatic formula which fits all people and is 100% safe for the human body”.^[5]Boos Labs, (no date). How it works. Available at: https://forgreyhair.com/how-it-works (Accessed: 30 January 2023

Oto Sova has, according to the website “studied in several scientific centers in Europe and was a student of several Nobel Prize winners”.^[6]For Grey Hair, (no date), For Grey Hair. Available at: https://forgreyhair.au/blog.html (Accessed: 29 January 2023

Who is their target consumer?

Reparex has products aimed at treating gray hair for both men and women. The case studies on their website include 11 men and 6 women.

What products do Reparex offer?

The Reparex range, including prices and volumes, is tabulated below.

Product	Size	Price
Reparex Against Grey Hair for Men	150ml	$54.95
Reparex Against Grey Hair for Women	150ml	$54.95
Reparex Against Gray Hair for Beard and Mustache	150ml	$54.95

Table 1: Prices of Reparex products. Adapted from:^[7]Reparex, (no date), Reparex Shop. Available at: https://reparexshop.com/usa/reparex-against-grey-hair/ (Accessed: 27 January 2023

Reparex also offers anti-dandruff lotions, shampoos, and skin ointments aimed at psoriasis sufferers.^[8]Reparex, (no date), Reparex Shop. Available at: https://reparexshop.com/usa/reparex-against-grey-hair/ (Accessed: 27 January 2023 These however are not part of the Against Grey Hair Range.

How do they claim these offerings are unique?

Reparex claims that their product is not a hair dye as, according to their definition, “hair dye colors your hair from the outside, but Reparex changes the hair color from the inside. It restores the original hair color, just as your hair was before it became gray”.^[9]Reparex, (no date), FAQ. Available at: https://reparexshop.com/usa/faq/ (Accessed: 27 January 2023

Quite what they mean by ‘’…changes hair color from the inside.’’ isn’t clear, and the data to support their claim to this mechanism (not to mention evidence that the product actually changes hair color) is lacking. This makes it difficult to determine whether this product is actually unique.

What is their pricing?

As can be seen above, you’re looking at spending $54.95 a bottle for the specific product you want in the Against Grey Hair series, which should last you around a month.^[10]Reparex, (no date), Reparex Shop. Available at: https://reparexshop.com/usa/reparex-against-grey-hair/ (Accessed: 27 January 2023

As there don’t appear to be other products that claim to do what Reparex does, there is not much to compare the price to. But, compared to standard hair dyes, which can be very cheap at around $10, this is perhaps on the pricier side.

Product Science: Deep Dive

Firstly, let’s give a brief overview of how melanin is formed and cover some reasons why hair might turn gray.

Melanin is a type of material in your hair that gives it its color. There are two types of melanin (eumelanin and pheomelanin) and these are both created by special types of cells called melanocytes. Melanocytes are present in both the skin and hair whose primary job is to create melanin. Eumelanin is a darker pigment and is responsible for darker hair color, and pheomelanin is responsible for lighter hair color. An individual person’s hair color will be based upon a specific amount of each type of melanin and their genetics.^[11]Slominski, A., Wortsman, J., Plonka, P.M., Schallreuter, K.U., Paus, R., Tobin D. (2005). Hair Follicle Pigmentation. Journal of Investigative Dermatology. 124(1), 13-21. Available at: … Continue reading

In the hair follicle, melanocytes undergo a cycle of growth (proliferation) and rest, in tandem with the hair follicle’s own growth (anagen) and non-growing (telogen) cycles. Specialized stem cells called melanocyte stem cells are located in the bulge of the hair follicle, are activated at the start of the hair follicle growing phase, and supply melanocytes to the core part (the matrix) of the hair follicle. Melanocytes then undergo multiple divisions so that there is a  continuous store of melanocytes (and therefore melanin) in the bulb of the hair follicle.^[12]Nishimura, E.K. (2011). Melanocyte stem cells: a melanocyte reservoir in hair follicles for hair and skin pigmentation. Pigment Cell & Melanoma Research. 24(3), 401-410. Available at: … Continue reading 

Melanin is then packaged into a small ‘packet’ called a vesicle (or a melanosome) which is then transferred into the cells that make the actual substance of the hair follicle (matrix keratinocytes).^[13]Schlessinger, D.I., Anoruo, M.D., Schlessinger, J. (2022). Biochemistry, Melanin, In: StatPearls, Treasure Island (FL). StatPearls publishing. Available at: … Continue reading Matrix keratinocytes are cells found in the matrix of the hair follicle, where they are highly proliferative (actively undergo cell division) to form the hair shaft you eventually see as your hair. 

The synthesis of melanin involves specific biochemical reactions (called redox reactions) which are made possible  by a couple of enzymes called tyrosinase and tyrosinase-related protein (TRP). These enzymes are involved at each step of the production of reactive oxygen species (ROS), such as hydrogen peroxide (H2O2) or O2- as can be seen in Figure 2. Redox reactions are chemical reactions in which a compound can either lose an electron (oxidized) or gain an electron (reduced).^[14]Denat, A., Kadekaro, A.L., Marrot, L., Leachman, S, Abdel-Malek, Z.A. (2014). Melanocytes as Instigators and Victims of Oxidative Stress. Journal of Investigative Dermatology. 134(6). 1512-1518 … Continue reading

ROS are chemical compounds that contain oxygen and are therefore highly reactive, so they readily interact with the environment around them. These can cause an environment called oxidative stress which, among other things, can cause damage to melanocytes and other cells in the hair follicle.^[15]NIH, (no date), Reactive oxygen species. Available at: https://cancer.gov/publications/dictionaries/cancer-terms/def/reactie-oxygen-species (Accessed: 30 January 2023

However, the hair follicle has a natural defense against ROS -an enzyme called catalase. Catalase breaks down hydrogen peroxide over a series of chemical reactions (also redox reactions), resulting in the production of water and oxygen, and providing protection against oxidative stress.^[17]Goyal, M.M., Basak, A. (2010). Human Catalase: Looking for Complete Identity. Protein & Cell. 1(10). 888-897. Available at: https://doi.org/10.1007/is13238-010-0113-z

While there are in-built mechanisms in place for reducing oxidative stress, these can be dysregulated by old age, radiation, inflammation, and psychological/emotional stress. It has been found that there is an increase in oxidative stress and death (apoptosis) of melanin-producing cells (melanocytes) in individuals with gray hairs, as well as a reduction of key protectors against oxidative stress, such as Bcl-2 (and catalase which we will go into further below) and growth factors involved in melanocyte growth such as c-Kit. This reduction in melanocytes subsequently leads to less melanin in hair shafts, giving hair a gray appearance (Figure 3).^[18]Arck, P.C., Overall, R., Spatz, K., Liezman, C., Handjiski, B., Klapp, B.F., Birch-Madin, M.A., Peters, E.M.J. (2006). Towards a “free radical theory of graying”: melanocyte apoptosis in the … Continue reading 

A further study compared isolated growing hair follicles, dermal papilla cells (DPCs), and other specialized hair follicle cells from gray- and brown-haired donors.^[20]Wood, J.M., Decker, H., Hartmann, H., Chavan, B., Rokos, H., Spencer, J.D., Hasse, S., Thornton, S.J., Shalbaf. M., Paus, R., Schallreuter, K.U. (2009). Senile hair graying: H2O2-mediated oxidative … Continue reading The researchers showed that catalase and other enzymes responsible for maintaining a healthy redox balance within the hair follicle are reduced in graying hair, leading to a negative cycle of imbalance and subsequent oxidative stress. In addition to this, hydrogen peroxide was also found to be present in the graying hair follicle whereas it was not present in the brown hair follicle. Furthermore, the researchers found that tyrosinase activity, the enzyme essential for facilitating the synthesis of melanin, was reduced after melanocytes were incubated with increasing doses of hydrogen peroxide (Figure 4).

So, it is generally thought that oxidative stress can build up through different stressors in addition to the reactive oxygen species naturally produced through the synthesis of melanin. When oxidative stress builds up, it can reduce the activity of melanocytes and even induce them to die. In these circumstances as there is no longer enough melanin produced to provide keratinocytes with the natural pigment and hairs become gray.

But what does all this have to do with Reparex?

Reparex states that “as we get older hair turns gray due to a natural build-up of hydrogen peroxide in the hair follicles, which causes oxidative stress which oxidizes melanin and consecutively causes graying”. Then they claim that “Reparex removes Oxygen from oxidized colorless  melanin using the enzyme g-reductase which binds with silver nitrate. This results in restoration of melanin’s natural color”.^[22]Reparex, (no date), How does it work? Available at: https://reparexshop.com/usa/reparex-against-grey-hair (Accessed: 29 January 2023

While the statement above is an attempt to explain the mechanism of action of the Against Grey Hair products, it does not seem to fit with the current theories that state that we lose melanin rather than have colorless melanin within our hair. Additionally,  the information on their website is quite confusing and inconsistent,  so the only thing we can do is try to break the product down and see how it might work.

The two main ingredients in Reparex’s Against Grey Hair products are silver acetate and glucuronate reductase. Reparex claims that “glucuronate reductase…was able to remove the oxygen from hair melanine [sic] and gives it to silver nitrate”.^[23]Boos Labs, (no date), Product Information File. Available at: https://www.forgreyhair.co.uk/wp-content/uploads/sites/12/2022/09/PIF-FGH.pdf (Accessed: 27 January 2023 

So, let’s see what these ingredients might do…

Silver acetate…or is it silver nitrate?

Reparex uses the terms silver acetate and silver nitrate interchangeably throughout its website. While they are superficially similar chemical names, they are certainly not the same chemical. In their reasoning for including these chemicals, Reparex state that when they just used the glucuronate reductase by itself it “…took away the oxygen and the hair darkened, but after a while, the hair turned gray again, because the enzymes had no place to transfer the taken oxygen and so they put it back in the hair…therefore it was necessary to engage some ‘oxygen scavenger’ and thus the addition of a minimum amount of silver acetate. As a result, For Grey Hair has become fully functional and usable”.^[24]Boos Labs, (no date), The single best treatment for gray hair invented by Oto Sova. Available at: https://forgreyhair.com.au/httpswwwforgreyhaircombest-treatment-for-grey-hair.c128.html (Accessed: 30 … Continue reading

However, with regard to silver acetate, we weren’t able to find any evidence to suggest that it can bind to oxygen or react with oxygen. Furthermore, there does not appear to be any precedence for using silver acetate in hair products. 

Silver nitrate, however, can react with oxygen. Furthermore, it has been used as a hair colorant.  used daily, it slowly darkens or lightens the hair. So, perhaps there is some rationale for including silver nitrate ^[25]Guerra-Tapia, A., Gonzalez-Guerra, E. (2014). Hair Cosmetics: Dyes. Actas Dermo-Sifiliográficas (English Edition). 105(9), 833-839. https://doi.org/10.1016j.adengl.2014.02.003

Glucuronate Reductase

Glucuronate reductase is an enzyme that belongs to a family of oxidoreductases. Oxidoreductases are enzymes that facilitate redox reactions.^[26]Legesse, H.B., Assefa, B.E. (2021). Biological Application and Disease of Oxidoreductase Enzymes. Oxidoreductase. Available at: https://doi.org/10.5772/intechopen.93328 With regard to  Reparex, we can hypothesize that it might work by facilitating a redox reaction in which hydrogen peroxide present in graying hair gets broken down, therefore clearing it from the hair. Perhaps this would reduce oxidative stress and prevent damage to melanocytes. Even if this was the case, would this mechanism still work to replenish already lost melanocytes? Perhaps not.

In any case, as there is no actual mechanistic data, all we can do is speculate and hypothesize, but is there any clinical information about whether this product actually works?

Does Reparex work as a hair treatment?

Unfortunately, there is no clinical data associated with this product that can tell us whether it actually works. There are some case study before-and-after photos presented on the Reparex website; however, some of these appear to actually be just the same photo twice, and it’s impossible to tell if some of the before-and-after photos are the same person, even if there are some notable changes. 

Additionally, Reparex offers “2 Free Reparex products of your choice for and before and after photos from our customers”.^[27]Reparex, (no date), Reparex Against Grey Hair. Available at: https://reparexshop.com/usa/reparex-against-grey-hair (Accessed: 30 January 2023 The problem with only having before-and-after photos and an incentive to provide them, is that it’s more likely that only people who have positive responses to the treatment will post their results. Furthermore, it’s possible that there are a number of people who saw no improvement, that Reparex may have chosen not to show. This can be avoided with pre-registered clinical trials with disclosed patient numbers, as they will need to show details for all the participants regardless of whether they show a response to the treatment or not.

So, there is no clinical data and no mechanism of action data, meaning that if we did want to use it, we have to trust Reparex and its unconvincing before-and-after photos. But can we actually trust them?

Other than the confusing information on the website about their own product, Reparex also has some somewhat shaky information in their FAQs which leads us to question their overall knowledge about hair. An example is:

“Q: Does REPAREX reduce hair loss?

A: According to latest scientific research, hair loss is caused by a lack of elements such as nickel and iron. We cannot say which one of these is particularly missing for each individual therefore REPAREX cannot help your hair to grow again but we can assure you that it will not cause hair loss to start nor make it worse if you are already suffering from hair loss. Our product has no effect on hair loss.”^[30]Reparex, (no date), FAQs. Available at: https://reparexshop.com/usa/faq/ (Accessed: 29 January 2023

While vitamin and mineral deficiency can certainly contribute towards hair loss, in reality, it’s not the only way that hair loss can develop.^[31]Almohanna, H.M., Ahmed, A.A., Tsatalis, J.P. (2019). The Role of Vitamins and Minerals in Hair Loss: A Review. Dermatology and Therapy. 9, 51-70. Available at: … Continue reading For example, androgenetic alopecia (AGA) can be caused by an overproduction or oversensitivity to androgens (such as dihydrotestosterone); telogen effluvium can be caused by multiple triggering events, including pregnancy; alopecia areata can be caused as a function of autoimmune dysregulation (to name a few).^[32]Alessandrini, A., Bruni, F., Piraccini, B.M., Starace, M. (2020). Common causes of hair loss – clinical manifestations, trichoscopy and therapy. Journal of the European Academy of Dermatology and … Continue reading

Is Reparex Against Grey Hair safe?

Reparex states that “REPAREX has been carefully tested according to the latest EC regulations for cosmetic products; this includes testing for heavy metal content, skin irritation, and any general harm. It has also been evaluated by independent Cosmetic Product Safety Assessors. Furthermore, REPAREX has also been registered at the Central Registration of Cosmetic Products in Brussels and according to its status as harmless it was released to the EU market as harmless and 100% legal.”^[33]Reparex, (no date) FAQ. Available at: https://reparexshop.com/usa/faq/ (Accessed: 29 January 2023

However, to our knowledge, there has been no published efficacy or safety data for this product, so we cannot say with certainty that this product is safe to use long-term. It’s also worth noting there are dozens of examples whereby short-term (i.e., 1-2 year) data suggested that a natural substance might be safe, only for long-term (i.e., 5-10+ year) data to show the exact opposite. One example: the effects of vitamin E and selenium supplements on prostate cancer. Short-term data suggested benefit, while long-term data showed these supplements doubled the rates of prostate cancer in men with already-adequate vitamin E and selenium levels.

Should I use Reparex?

You may consider trying out this product if:

• You are unhappy with your gray hair
• You do not want to use other hair dyes
• You are happy using products that have no efficacy or safety data
• You are ok buying a product from a company that has confusing and incorrect information on their website

You may be better placed however to just use a standard hair dye, which you can buy for a fraction of the price.

Recommendations to the company

We would recommend that Reparex look at the information that they are showing on their websites and make sure that it is consistent with (1) the actual ingredients in the product and (2) current scientific data. Furthermore, we recommend that Reparex conduct some mechanistic and long-term pre-registered clinical trials to determine the efficacy and safety of Reparex as a product that can reverse hair graying. Additionally, Reparex should address the issues with their before-and-after photos and make sure that they are not the same photos, and that people can be clearly identified as the same person.

Final thoughts

If you are comfortable trying products with zero published clinical or mechanistic data, and you do not want to use hair dyes, then Reparex might be something you could consider experimenting with. Otherwise, we do not recommend using this product in its current state.

Is hair loss treatment lifelong? It can be daunting to think that’s the case, as it seems quite a commitment. But while it’s true for most cases of androgenic alopecia, lifelong hair loss treatment may not be as scary as it seems. In this article, we will delve into the effects of stopping hair loss treatments and how a shift in perspective can improve how we feel about “lifelong” hair loss treatments. 

Is Hair Loss Treatment Lifelong?

The short answer is yes: hair loss treatments must be continued, or results gained will be lost. This is at least true for most cases of androgenic alopecia (more on this below). The longer answer is that:

• This isn’t true for all hair loss cases. There are plenty of situations where hair loss treatments are only temporary, as the hair regrowth sustains even after quitting. It depends on the type(s) of hair loss.
• “Lifelong” treatments aren’t as scary as they seem. The fact that some treatments might require a lifelong commitment should never be a reason not to try that same treatment, at least today.

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Let’s first look at what we know about what happens when you quit a hair loss treatment.

What Happens if I Quit a Hair Loss Treatment?

Luckily, some studies explain what happens when you quit traditional hair loss treatments like minoxidil and finasteride. There is even a study looking at what happens if you stop microneedling.

What Happens if I Quit Minoxidil?

In 1999, a study explored the implications of discontinuing minoxidil after long-term use. The study yielded intriguing results, as the group that ceased minoxidil treatment observed a period of increased hair shedding and a temporary drop in hair counts, falling below their pre-treatment levels.

Four groups of 9 men with AGA were followed over two years, with each group receiving either 2% minoxidil, 5% minoxidil, a placebo, or no treatment. The 2% and 5% minoxidil groups displayed a notable increase in hair counts after three months, which reached a plateau but remained higher than those observed in the placebo and control groups.

Approximately two years into the study, at the 96-week mark, the individuals in the 2% and 5% minoxidil groups stopped their treatments. This discontinuation is evident in the data related to hair weights, which began to decline shortly afterward (see Figure 1). Three months later, around week 108, their hair loss had fallen well below the levels seen in the placebo group, even dipping below their initial hair counts. However, by week 120, three months later, the 2% and 5% minoxidil groups had rebounded and returned to a level comparable to their baseline hair counts before the study began.

It should be noted that any excess hair shedding experienced during this transition phase is usually not a permanent condition. With time, the hair adjusts to a new equilibrium without the presence of the drug, and excessive shedding should subside, returning to pre-treatment levels.

What Happens if I Quit Finasteride?

The informational insert for Propecia, a finasteride brand, indicates that hair loss typically resumes within 3 to 12 months after stopping the medication, and hair counts may revert to pre-treatment levels. This conclusion is grounded in the results from Phase II and III clinical trials, which were crucial for the FDA’s approval of finasteride for treating androgenic alopecia.

In these trials, a subset of participants received finasteride for an entire year. Subsequently, they were unknowingly switched to a group that received a placebo (a sugar pill) during the second year, corresponding to months 12-24 of the study. The researchers closely monitored and documented changes in hair counts for these participants from the start (month 0) throughout 24 months. They then compared these changes with those who continued using finasteride throughout the study and those who consistently received the placebo.^[2]Kaufman, K.D., Olsen, E.A., Whiting, D., Savin, R., DeVillez, R., Bergfeld, W., Price, V.H., van Neste, D., Roberts, J.L., Hordinsky, M., Shapiro, J., Binkowitz, B., Gormley, G.J. (1998). Finasteride … Continue reading

What the Findings Say

The study revealed that ceasing finasteride and switching to placebo resulted in hair counts falling back to their initial levels, or even slightly below, within 12 months after stopping the medication (Figure 2).

However, there are also interesting studies that can provide information about taking a break from finasteride.

Biological Effects of Finasteride After Quitting

Because finasteride has a terminal half-life of 5-7 hours, and it takes about 4-5 days for the drug to fully dissociate from tissues, its biological effects on hormone profiles can persist for approximately 30 days after discontinuation.

In practical terms, this means finasteride can continue to have a therapeutic impact in reducing scalp levels of dihydrotestosterone (DHT) even several weeks after discontinuing the medication (see Figure 3).

Exploring Alternative Finasteride Dosing Schedules

A study investigated whether a daily dose of 1 mg was necessary to maintain hair regrowth. Initially, a group of men was placed on a daily 1 mg finasteride regimen for a year. In the second year, the men were divided into two groups: one continued to take finasteride daily, while the other group adopted a 30-days-on, 30-days-off dosing schedule.^[5]Kim, K.H., Park, S.M., Lee, Y.J., Sim, W.Y., Lew, B.L. (2020). Similar efficacy of maintenance treatment of finasteride 1 mg every other month compared with finasteride 1 mg daily in Korean men with … Continue reading

The second group used finasteride for only half the time (i.e., 6 months as opposed to 12 months), yet both groups experienced similar improvements in hair parameters during the second year.

The underlying hypothesis for this result was that finasteride’s pharmacokinetics might allow for dosing schedules that alternate monthly. This approach could potentially accommodate those who wish to reduce their drug exposure or take breaks from the medication without significantly compromising their hair gains.

What If I Need To Stop Taking Finasteride For Any Other Reason?

When pausing finasteride use for an extended period exceeding 30 days, there is a higher risk of hair loss resuming due to the dissipation of the drug’s effects on scalp DHT levels. Both clinical withdrawal studies and anecdotal reports from finasteride users support this phenomenon.

Hair loss may not immediately return for many individuals but might become noticeable around the second or third month after quitting. To maintain the benefits of the drug on hair health, it is advisable to keep the withdrawal period beyond 30 days as short as possible.

If you want to learn more about the pharmacokinetics of finasteride and how you can maximize your treatment usage, you can follow these links:

• Finasteride: How Long Does It Stay In The Bloodstream?
• Finasteride: How Long Does It Stay Active in Scalp Tissue?
• What Happens If I Stop Using Finasteride?

What Happens if I Quit Microneedling?

Currently, there is only one clinical study evaluating the effects of microneedling cessation. This study compared the effects of using minoxidil only, microneedling only, and using both minoxidil and microneedling together.^[6]Bao, L., Zong, H., Fang, S., Zheng, L.i, Y. (2022). Randomized trial of electrodynamic microneedling combined with 5% minoxidil topical solution for treating androgenetic alopecia in Chinese males … Continue reading

The study involved 71 male participants with androgenetic alopecia (AGA), divided into three distinct treatment groups:

1. 5% minoxidil applied twice daily for 24 weeks (23 participants).
2. Microneedling sessions were conducted every 3 weeks, totaling 8 treatments (23 participants).
3. A combination of both treatments over 24 weeks (25 participants).

The researchers assessed changes in hair density and diameter at three-week intervals and conducted a six-month follow-up after the final treatment.

What the Findings Say

All groups exhibited significant increases in non-vellus hair density three weeks post-treatment. Notably, the combination group showed the most substantial increase in non-vellus hair density (56.45±7.82 roots per cm²), outperforming the ~28 increase in the minoxidil group and ~32 in the microneedling group.

These findings align with earlier research, particularly a paper by Dhurat et al., highlighting microneedling’s role in enhancing minoxidil’s effectiveness.

Six-Month Follow-Up Insights

Six months after the completion of the treatments, the study revealed intriguing long-term effects:

• In the minoxidil-only group, 90% of participants lost all newly acquired hair within six months post-treatment cessation, a finding consistent with previous minoxidil research.
• Conversely, in both the microneedling-only and the combination groups, 70% of participants retained some new hair, and 20% maintained all new hair growth (referenced in Figure 4).

Figure 4 illustrates the comparative hair regrowth across the three groups during the initial 24 weeks of treatment and the subsequent 24 weeks post-treatment.

These results suggest that microneedling, alone and in combination with minoxidil, offers more durable effects on hair maintenance, even after treatment discontinuation. The sustained impact in the combination group also indicates that microneedling may enhance minoxidil’s long-term effectiveness.

In summary, while managing hair loss often requires lifelong treatment, there are instances where benefits can continue even after the cessation of certain therapies. Studies have shown that minoxidil and finasteride necessitate ongoing use to maintain hair growth, as discontinuation can reverse benefits. However, treatments such as microneedling, alone or in combination with minoxidil, have demonstrated more enduring effects, offering sustained hair maintenance even after stopping the treatment.

How Can We Change Our Mindset About “Lifelong” Hair Loss Treatments?

Changing our mindset about lifelong hair loss treatment involves embracing it as a part of routine self-care, much like daily exercise or a balanced diet. It’s about viewing these treatments not as burdensome but as an empowering step toward self-confidence and well-being. Recognizing that consistency is key to success, we can integrate these treatments into our daily routines.

Let’s take a look at some ways that we can improve our mindset about long-term treatment.

1. Let hair care become part of a daily self-care routine.

Taking care of our hair is important to our overall health and well-being. We all have a daily skincare routine to maintain our skin’s health and appearance, and we can apply the same principles to our hair care routine.

Hair loss treatments should be viewed as a constructive practice that can help preserve and enhance our natural features. Whether we choose to use topical solutions, medications, or nutritional supplements, these treatments can help us maintain the health and vitality of our hair.

By adopting this mindset, we can reframe hair loss treatment as a positive and nurturing practice that empowers us to take control of our hair’s health, just like how we care for our skin, caring for our hair can be a normal and rewarding part of our daily wellness routine.

Another perspective:

2. Starting treatment today does not mean committing to that treatment forever.

Research shows that when someone quits treatment, their hair loss will resume. Within several months, their hair will return to its state before treatment. As you can see above, minoxidil users typically experience a loss of gains within 3-6 months, with an initial excess shedding period and then a return to baseline. For finasteride users, that timeframe is often 6-12 months (or longer), and quitting microneedling can take over 6 months to lose hair gains. 

Importantly, those same studies show people are never worse off after starting and then quitting hair loss treatments. 

This is critical because it means there is little risk when trying a hair loss treatment and later withdrawing it. By doing so, hair loss is not accelerated; it simply returns to baseline after quitting. In effect, the time spent on the treatment has slowed the progress of future hair loss.

It’s significantly easier to arrest the progression of hair loss than to regrow hair. That means that when fighting hair loss, time is of the essence. We speak about this in our treatment mistakes video series, which is available for members, particularly in the videos about balding speeds.

As such, trying a treatment today does not require a lifelong commitment to that treatment. Just by giving that treatment a shot, the rate of hair loss potentially slows down. If a decision is made later to quit or taper away from that treatment, the data strongly suggest that your efforts should never make things worse in the long-run.

Do Any Hair Loss Treatments Work Permanently, Even After Quitting Them?

For some cases of telogen effluvium and alopecia areata, yes. There may be conditional situations where this might be true for scarring alopecias.

For cases of androgenic alopecia, the clinical data suggests hair loss treatments need to be lifelong. Some studies have indicated that adding microneedling to minoxidil might enhance the staying power of minoxidil’s hair gains by several months,  even 6+ months after quitting both interventions.

We talk about these phenomena in this video. Remember that the data are preliminary, so don’t quit any treatments because of that study. 

So, why not take action now and begin a regrowth protocol to put yourself in the best possible future position? Any progress made will, at the very least, slow down the progression of hair loss over time, providing benefits even without a lifelong commitment to treatment.

When it comes to microneedling vs. platelet-rich plasma, which is better? Dermatologists often recommend platelet-rich plasma therapy (PRP) as a treatment for hair loss. This autologous therapy evokes the body’s natural healing response, as does microneedling. We look at what the research studies say about the effectiveness of these two treatments. Time and cost factors are also important considerations for most people.

Interested in Topical Minoxidil?

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Take the next step in your hair regrowth journey. Get started today with a provider who can prescribe a topical solution tailored for you.

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*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

What is Microneedling?

Microneedling, a minimally invasive cosmetic procedure, has emerged as a promising treatment for various forms of hair loss, including androgenic alopecia (AGA). This technique involves using specialized devices, like rollers of pens, equipped with fine needles to create controlled micro-injuries on the scalp.

These micro-injuries stimulate the body’s natural wound-healing processes, enhancing blood flow and promoting the release of growth factors essential for hair regeneration. This method not only improves hair density and thickness but also increases the efficacy of topical hair growth products by facilitating deeper penetration into the scalp.^[1]Dhurat, R., Sukesh, M.S., Avhad, G., Dandale, A., Pal, A., Pund, P. (2013). A Randomized Evaluator Blinded Study of Effect of Microneedling in Androgenetic Alopecia: A Pilot Study. International … Continue reading,^[2]English, R.S., Ruiz, S., DoAmaral, P. (2021). Microneedling and Its Use in Hair Loss Disorders: A Systematic Review. Dermatology and Therapy. 12. 41-60. Available at: … Continue reading

What is Platelet-Rich Plasma Therapy?

Platelet-rich plasma (PRP) therapy is increasingly recognized as an effective treatment for hair loss, particularly AGA. This procedure involves drawing a patient’s blood, processing it to concentrate platelets and growth factors, and injecting this enriched plasma into the scalp.

PRP therapy stimulates hair follicles, promotes new hair growth, and enhances hair density and thickness. The growth factors and proteins in PRP promote tissue repair and regeneration, making it a promising non-surgical option for hair loss. Clinical studies have also demonstrated the efficacy of PRP in improving hair count and thickness in individuals with hair loss.^[3]Gentile, P., Garcovich, S., Bielli, A., Scioli, M.G., Orlandi, A., Cervelli, V. (2015). The Effect of Platelet-Rich Plasma in Hair Regrowth: A Randomized Placebo-Controlled Trial. Stem Cells … Continue reading,^[4]Cervantes, J., Perper, M., Wong, L.L., Eber, A. E., Fricke, A.C.V., Wikramanayake, T.C., Jiminez, J.J. (2018). Effectiveness of Platelet-Rich Plasma for Androgenetic Alopecia: A Review of the … Continue reading

Microneedling vs. PRP: Which Is Better?

When hair loss patients visit dermatologists for advice, it’s not uncommon for those physicians to recommend autologous therapies. These hair loss therapies, such as platelet-rich plasma (PRP) therapy, PRP + Acell, adipose-derived stem cells, exosomes, and others, are derived from our tissues. These treatments must be conducted in a clinical setting and administered by a healthcare professional. While there is scientific evidence behind these therapies, it is also a significant cash cow for dermatologists, so it is no surprise that they recommend this treatment.

What these dermatologists won’t tell patients is that there is an alternative to PRP that:

1. Can be administered at home
2. Leverages the exact same mechanisms of action as PRP
3. Costs just a fraction of the price (usually 0.1% of the cost of a single PRP session)
4. Might be just as effective as PRP

That alternative is microneedling.

What Does the Clinical Evidence Say?

Two randomized, blinded, controlled clinical trials indicate that microneedling produces the same hair parameter improvements as PRP. Let’s take a closer look at these studies and determine if PRP has any benefits over microneedling.

Study 1 – Split Scalp Study Comparing Microneedling Alone to Microneedling with PRP

This one-year-long study included 30 male patients with varying degrees of androgenic alopecia. Each participant received treatments on different halves of their scalp – one half received microneedling only, and the other half of the scalp received microneedling and PRP together. The treatments were conducted over four months, with a follow-up evaluation three months after the final session. The effectiveness was measured using dermoscopic microphotographs and patient satisfaction scores.^[5]Aggarwal K, Gupta S, Jangra RS, Mahendra A, Yadav A, Sharma A. Dermoscopic Assessment of Microneedling Alone versus Microneedling with Platelet-Rich Plasma in Cases of Male Pattern Alopecia: A … Continue reading

The Results

• Hair Thickness and Density: Both treatments significantly improved hair thickness and density. The microneedling-only group nearly doubled the increase in hair thickness compared to the microneedling and PRP groups, though the difference between the groups was not statistically significant (Figure 1).
• Patient Satisfaction: Most patients reported moderate satisfaction with the treatment outcomes, noting reduced hair loss but not necessarily new hair growth.
• Long-Term Effects: A follow-up revealed that some patients experienced a recurrence of hair loss, indicating the need for ongoing or maintenance treatments.

The Conclusion

Both microneedling and PRP can effectively treat androgenic alopecia and improve hair parameters and patient satisfaction. However, adding PRP to microneedling did not show any significant additional benefits over microneedling alone.

Study 2 – PRP Compared to Saline Injection

Another study was conducted with 26 women with female pattern hair loss. The women were randomly assigned to receive either 10 mL of PRP or a normal saline placebo. The study’s primary endpoints were hair count and hair mass index (HMI), measured at baseline and after 26 weeks. Additionally, a patient survey was conducted to gauge personal perceptions of treatment effectiveness.^[7]Puig CJ, Reese R, Peters M. Double-Blind, Placebo-Controlled Pilot Study on the Use of Platelet-Rich Plasma in Women With Female Androgenetic Alopecia. Dermatol Surg. 2016 Nov;42(11):1243-1247. Doi: … Continue reading

The Results

• Hair Count and Mass: There was no statistically significant difference between the PRP and placebo groups regarding hair count and HMI after 26 weeks. This suggests that the needle insertion and the subsequent acute inflammation may be the reason for the improvement in hair growth, rather than the injection and the PRP (spoiler alert, you can get the same effect from just microneedling).
• Patient Survey: A small percentage (13.3%) of the treatment group reported substantial improvement in aspects like hair loss rate, hair thickness, and ease of hair management compared to the placebo group. However, these subjective improvements did not align with the objective measurements of hair count and HMI.

The Conclusion

This study, despite being well-designed, did not demonstrate a significant advantage of PRP over placebo in treating female androgenetic alopecia. The findings suggest that further research is needed to fully understand the role of PRP in hair loss treatment, including the possible contribution of the injection process beyond the growth factors in PRP.

So, it’s not looking great for PRP compared to microneedling. But are there any other redeeming qualities?

What About the Cost?

We know that PRP can improve hair loss outcomes, but it does not appear to be any more effective than microneedling. So does the cost make it more appealing?

No.

PRP is several times more expensive than microneedling. Let’s break it down a bit.

Microneedling Cost-Benefit

Let’s start with the costs:

• Initial investment: A microneedling device (roller or pen) can range from $10 – $200 for at-home devices.
• Replacement costs: Needles or cartridges, if applicable.
• Maintenance: Limited to cleaning and sterilizing the device.

Now, let’s see the benefits:

• Effectiveness: Proven to improve hair thickness and density in several studies.
• Convenience: This can be done at home.
• One-time cost: Mostly just the initial investment; very low ongoing costs.

Platelet-Rich Plasma Cost-Benefit

Costs:

• Per Session Cost: Each PRP session can range from $400 – $1300, depending on material quality and where you go.
• Annual cost: $1500 – $10,000 (assuming 3-4 sessions)
• Frequency: Initially, multiple sessions are needed, often 3-4 per year
• Maintenance: Every 6 – 12 months after the initial treatment to maintain hair regrowth.

Benefits:

• Effectiveness: Clinical studies show that it can stimulate hair growth and increase hair density (though microneedling can produce the same results).
• Professional Supervision: Performed by medical professionals, offering expertise and safety.

Based on the above information, it’s safe to say that you get more for your money with microneedling, given its effectiveness and significantly lower costs.

What About the Convenience / Ease of Use?

Several key differences become apparent when comparing the convenience and ease of use between microneedling and PRP.

Microneedling

Microneedling is notably convenient, especially with at-home devices. It allows individuals to perform the treatment at their own pace and in the comfort of their own homes, eliminating the need for frequent clinic visits. Furthermore, these devices are relatively straightforward to use. After an initial learning curve, users can quickly integrate the treatment into their routine. These sessions can also be relatively quick, often taking less than 10 minutes, and can be easily scheduled around personal routines and commitments.

If you want to learn more about integrating microneedling into your routine, look at our Ultimate Guide here.

Platelet-Rich Plasma

PRP therapy, on the other hand, is less convenient compared to microneedling due to the necessity of visiting a clinic or a healthcare provider for each session. This requires scheduling appointments, possibly taking time off work, and traveling to the clinic.

It is also not a self-administered treatment. It requires a skilled medical professional to draw the blood, process it to concentrate the platelets and inject it into the scalp. The process is more complex and clinical compared to miconeedling. Moreover, each PRP session, including preparation and treatment, takes longer than a typical microneedling session (treatment alone can take ~1 hour!), and the need to schedule and attend clinic appointments adds to the time commitment.

Overview Comparing Microneedling and PRP Therapy

Take a look at this overview table that we’ve created to get a quick comparison between the two treatments.

Criteria	Microneedling	PRP Therapy
Effectiveness	Similar improvements in hair count and thickness in comparative studies.
Cost per Session	Relatively low; cost primarily involves the purchasing of a microneedling device. This can range from less than $10 for a derma roller to ~$80+ for a derma pen. If you want an aesthetician to do it for you, it can cost $50 – $150 per session.	Higher. It involves the cost of blood draws, processing, and injections per session. The cost of just one injection can range anywhere from $400 – $1300, depending on the materials’ quality and where you go for treatment.
Total Cost for Treatment	There is a one-time cost for the device, which can be reused multiple times.	Treatments (3-4 rounds) could cost $1500 – $10,000.
Session Frequency	It can vary; typically, once a week to once every few weeks.	Every 4-6 weeks for the first 3-4 months, then maintenance treatments every 6- 12 months.
Ease-of-Use/Convenience	You can perform it at home but must learn the proper technique.	A healthcare professional must perform it in a clinical setting.
Recovery Time/Side Effects	Minimal; may include temporary redness or irritation.	Minimal; may include scalp tenderness, swelling, or mild pain at the injection sites.
Longevity of Results	Long-term consistent use is required for sustained results – however, some benefits may be retained even after the stoppage of treatment.	Periodic maintenance sessions are needed for sustained results.

In addition to saving time and money (which can amount to tens of thousands of dollars), it’s important to be cautious when following a dermatologist’s recommendation for PRP or any other autologous hair growth therapy. Instead, when weighing the options between microneedling and PRP, it may be wise to consider the benefits of microneedling.

How Does Microneedling Improve Hair Growth?

Microneedling is not just a superficial treatment; it has the ability to enhance hair growth by stimulating biological responses within the skin’s layers. This process involves the stimulation of the scalp at different depths, which activates a cascade of healing and rejuvenating mechanisms that are crucial for promoting healthier and thicker hair. Microneedling may contribute to hair regrowth by enhancing the effectiveness of topical treatments and stimulating the body’s natural healing processes. Let’s explore in more detail how microneedling can help with hair regrowth.

Enhances Drug Penetration

At shorter needle lengths (0.25 mm to 5 mm), microneedling can enhance the absorption and penetration of topical hair growth products such as minoxidil. By creating microchannels in the scalp, microneedling facilitates the delivery of these products to hair follicles, potentially maximizing their effectiveness. However, these needle lengths likely won’t evoke the growth factors necessary to encourage hair follicle proliferation.

Induces Growth Factor and Protein Secretion

At longer needle depths (1.5 mm to 2.5 mm), microneedling punctures the vascular networks in the dermis, which induces the release of growth factors and proteins. The body perceives these micro-injuries as wounds and activates an acute inflammatory response. Inflammation is a natural defense mechanism that recruits various cells and molecules to the injured site.

As part of this inflammatory wound-healing process, platelets in the blood release growth factors such as platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-β), and fibroblast growth factor (FGF). These growth factors are crucial in signaling nearby cells, including fibroblasts and keratinocytes. They stimulate these cells to migrate to the wounded area and begin tissue repair.

Fibroblasts in the scalp’s dermal layer (more on this below) respond to these growth factors by producing collagen and other proteins. Collagen is essential for the structural support of tissues, and it contributes to the overall health and strength of hair follicles.

Stimulates Bulge Stem Cells

Another aspect of the wound healing response is the activation of bulge stem cells. The bulge is a region located in the outer root sheath of the hair follicle, just below the sebaceous gland (Figure 2). It’s recognized as a niche for adult stem cells, essential for the regeneration and growth of hair follicles. These bulge stem cells can give rise to the various cell types that form the hair shaft and its surrounding structures. Activation of these cells is important for hair cycle progression and repair after injury.

(May) Promote Angiogenesis

Another suspected mechanism of microneedling is tissue remodeling, particularly in the form of angiogenesis: the formation of new blood vessel networks. The micro-injuries sustained during microneedling might stimulate increased blood circulation to the treated area, along with growth factors which, over a number of repeated sessions, might help grow new blood vessels in the microvascular networks supporting thinning hair follicles.. This increase in blood flow might deliver more essential nutrients and oxygen to hair follicles, which might improve their growth.

Note: microneedling-induced angiogenesis has been demonstrated in mouse models. However, it has not (yet) been demonstrated in human scalps – because the studies haven’t yet been conducted.^[5]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5064188/ It’s suspected that repeated microneedling would also promote angiogenesis in human scalps. However, confirming this would require invasive and repeated biopsies from humans pre- and post-microneedling, which acts as a deterrent for human study. As more research is published, we’ll update this article.

(May) Reduce Scalp Fibrosis

Another suspected effect from microneedling is the potential reduction of scalp fibrosis or scarring, a common feature in individuals with AGA. Scalp fibrosis can hinder hair follicle function and might even drive aspects of hair follicle miniaturization. Microneedling has shown promise in breaking down scar tissue (for example, in acne patients). It’s not unreasonable to assume a similar histological effect might also occur in the scalp, and potentially promote a healthier scalp environment for hair growth. As is the case with angiogenesis, as research develops, we’ll update this article.

How is Microneedling Applied?

CB-03-01, also known as Breezula™ or clascoterone, is a topical medication generating interest as a potential therapy for androgenetic alopecia (AGA). It was developed by Cassiopea (now owned by Cosmo Pharmaceuticals) and is a synthetic androgen receptor antagonist. While it is primarily recognized for its potential in combating hair loss, particularly AGA, CB-03-01 has also exhibited efficacy in treating conditions like acne, hirsutism, polycystic ovary syndrome (PCOS), and seborrheic dermatitis. In this overview, we look at whether  CB-03-01  can impact hair follicles and its potential in treating hair loss, and we will also look at CB-03-01’s safety profile and mechanism of action, drawing from clinical trials and research findings.

Key Takeaways

• Drug. CB-03-01, also known as Breezula™ or clascoterone, is a topical synthetic androgen receptor antagonist developed by Cassiopea (now owned by Cosmo Pharmaceuticals). It competes with natural androgens like dihydrotestosterone (DHT) for binding to androgen receptors, making it a promising treatment for hair loss that may be caused by androgen signaling, particularly androgenetic alopecia.
• Clinical Data. Three Phase II trials for CB-03-01 have been conducted – two for male and one for female AGA – the results of one of these trials were not published. The published studies are summarized below:
  • Study 1: A study involving 293 women aged 18-55 with AGA. Of various treatments used, a 5% formulation of CB-03-01 was the only treatment that significantly improved, and only in women under 30.^[1]Cassiopea Spa, (2021). Cassiopea SpA Announces Topline Results of Phase II Proof of Concept Trial of Clascoterone Solution for the Treatment of Androgenetic Alopecia in Females. Bloomberg. Available … Continue reading 
  • Study 2: A study involving 400 men aged 18-55 with mild to moderate AGA.  A 7.5% concentration of CB-03-01 led to statistically significant improvements in hair length and width in the treated area. All treatment groups showed relative improvement compared to the control.^[2]Cassiopea Spa, (2021). Cassiopea Announces Very Positive Phase II Twelve Months Results for Breezula® (Clascoterone) in Treating Androgenetic Alopecia Bloomberg. Available at: … Continue reading 
  • Phase III trials of CB-03-01 are expected to be completed in January 2025.
• Safety. CB-03-01 has reportedly demonstrated minimal side effects, with common issues being mild skin reactions such as scaling, redness, and itching. However, there is too little published data to make a definitive statement regarding the safety of CB-03-01.
• Evidence Quality. CB-03-01 scored 36/100 for evidence quality by our metrics.
• Best Practices. This product is not currently available at a 5% concentration for treatment of AGA. However, when available, this may be most effective when used twice daily by women with AGA under 30, based on the available data.

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What is CB-03-01?

CB-03-01, known by its brand name Breezula™ or clascoterone, is a topical synthetic androgen receptor antagonist owned by Cosmo Pharmaceuticals.^[3]Cosmo, (no date). Breezula. Cosmo Pharmaceuticals Available at: https://www.cosmopharma.com/pipeline/breezula (Accessed: 17 October 2023) An androgen receptor antagonist is a substance that can interfere with or block androgen hormones from working as they normally would.^[4]Kokal, M., Mirzakhani, K., Pungsrinont, T., Baniahmad, A. (2020). Mechanisms of Androgen Receptor Agonist- and Antagonist-Mediated Cellular Senescence in Prostate Cancer. Cancers (Basel). 12(7). … Continue reading CB-03-01 is a competitive antagonist, meaning it competes with natural androgen hormones in our bodies, such as dihydrotestosterone (DHT), for binding to the androgen receptor. CB-03-01 is primarily recognized for its potential in treating hair loss, particularly androgenetic alopecia. However, it has also been used to treat acne (under the brand name Winlevi), hirsutism (excess/unwanted facial hair in women), polycystic ovary syndrome (PCOS), and seborrheic dermatitis (Figure 1).

How Does CB-03-01 Work?

The mechanism of action of CB-03-01 (clascoterone) involves its interaction with androgen receptors in the skin, particularly in hair follicles and sebaceous glands. This compound is a selective androgen receptor antagonist with a specific affinity for androgen receptors.^[6]Cosmo, (no date). Breezula. Cosmo Pharmaceuticals Available at: https://www.cosmopharma.com/pipeline/breezula (Accessed: 17 October 2023) Androgens are a group of hormones that include testosterone and dihydrotestosterone (DHT), which play a role in the development and growth of hair, but which can also contribute to conditions like androgenetic alopecia (AGA, also known as male pattern hair loss) and acne when androgen hormone activity becomes abnormal or excessive.^[7]Handelsman, D.J. (2020). Androgen Physiology, Pharmacology, Use and Misuse. Endotext [Internet]. South Dartmouth (MA). Available at: https://www.ncbi.nlm.nih.gov/books/NBK279000/ (Accessed: 17 … Continue reading

Androgens like DHT normally activate androgen receptors to mediate their biological effects. CB-03-01 interferes with the ability of androgens to activate these receptors. In the context of hair loss, reducing androgen signaling can help slow down the miniaturization of hair follicles associated with androgenetic alopecia. By reducing the impact of androgens on hair follicles, CB-03-01 may help prevent hair follicle miniaturization and hair loss.

What is the Impact of CB-03-01 on Hair Follicle Biology?

There is one in vitro (or ‘test tube’) study that we could find that looks at how CB-03-01 could affect hair follicle biology. The study looked at dermal papilla cells (DPCs), which can be thought of as the hair follicle’s signaling center and which are negatively affected by testosterone in patients with AGA. DPCs from balding scalps grow slower than those of healthy scalps. They undergo a process called premature senescence, in which cells lose their ability to divide and grow.^[8]Bahta, A.W., Farjo, N., Farjo, B., Philpott, M. Premature senescence of balding dermal papilla cells in vitro is associated with p16(INK4a) expression. Journal of Investigative Dermatology. 218(5). … Continue reading 

Firstly, the researchers wanted to show that CB-03-01 could, in principle,  interfere with androgen receptor signaling. They used an experimental tool called androgen receptor reporter cells, which are commonly used to study the activity of androgen receptors. These cells were treated with 0.4 nM testosterone in the presence or absence of CB-03-01 or finasteride. The IC₅₀ value –  the drug concentration required to give half the maximal response  – was then calculated. CB-03-01 (called clascoterone here) had an IC₅₀ of  1.55×10^-6M, compared to 2.89×10^-6 M for finasteride. As a lower IC₅₀ value indicates that a drug is more effective, the results show that clascoterone is at least as potent as finasteride in inhibiting testosterone-induced androgen receptor activity; their IC₅₀ values are in the same order of magnitude (Figure 2).^[9]Rosetter, C., Rosette, N., Mazzetti, A., Moro, L., Gerloni, M. Cortexolone 17ɑ-Proprionate (Clascoterone) is an Androgen Receptor Antagonist in Dermal Papilla Cells in Vitro. Journal of Drugs in … Continue reading 

The researchers then treated reporter cells with 200 μM DHT with or without finasteride or CB-03-01 under three conditions (Figure 3).

1. Treated with DHT plus androgen receptor inhibitor (finasteride of CB-03-01) for 24 hours (to mimic once-daily application)
2. Treated with DHT plus androgen receptor inhibitor for 12 hours, then washed off and treated with DHT alone for a further 12 hours (to mimic once daily application and examine the metabolism of the drug)
3. Treated with DHT plus androgen receptor inhibitor for 12 hours, then washed off and treated with DHT plus androgen receptor inhibitor for a further 12 hours (to mimic twice-daily application)

In conditions 1 and 3, where CB-03-01 was continuously present, AR activity was significantly inhibited. This suggests that continuous exposure to the inhibitor effectively blocks androgen receptor activity. In condition 2, where CB-03-01 was removed after 12 hours, and the cells were exposed to DHT alone, the inhibitor’s effectiveness significantly decreased. The drug’s IC₅₀ was much higher in this case. This indicates a need for a continuous presence of the inhibitor for sustained antagonism of DHT-induced AR activity. The study also found finasteride was more effective when present for 24 hours than 12 hours (Figure 3), and CB-03-01 seemed to be as effective as finasteride at a similar concentration.

 

DPCs were treated with 200 μM DHT or vehicle control (0.1% DMSO) for 24 hours. The researchers found that exposure to high levels of DHT increased the expression of the androgen receptor in healthy dermal papilla cells. This mimicked the conditions found in the balding scalp, where DHT sensitivity contributes to hair loss. Additionally, the experiment revealed that exposure to high levels of DHT significantly increased the secretion of two cytokines: Interleukin-6 (IL-6) and basic fibroblast growth factor (bFGF) by DPCs (Figure 4A & B). 

The researchers then investigated whether clascoterone (CB-03-01) could antagonize the synthesis and secretion of these cytokines. They used enzalutamide as a positive control because it also acts as an androgen receptor antagonist, competing with DHT for binding to the androgen receptor. However, it would have been more useful to compare to finasteride, which is commonly used to treat AGA.

Clascoterone was found to be more effective at reducing the secretion of IL-6 compared to enzalutamide. The IC₅₀ (the concentration at which it inhibits 50% of IL-6 secretion) for clascoterone was much lower than that of enzalutamide, indicating that clascoterone more effectively reduced the secretion of this inflammatory cytokine (Figure 4B). However, neither of the drugs had any effect on bFGF (Figure 4C). 

The researchers finally performed cell viability assays to ensure the results were not due to cell death – this is important because cell viability changes could affect cytokine secretion. These assays showed that neither clascoterone nor enzalutamide significantly affected cell viability, indicating that the results were not an artifact caused by variations in cell death (Figure 4D).

 

So, we know that CB-03-01 can effectively compete with DHT for the androgen receptor, reducing the harmful effects of the hormone. However, these experiments were conducted in cells in a dish. Let’s move on to studies conducted on human patients.

Is CB-03-01 Clinically Effective at Treating Hair Loss?

CB-03-01 has undergone three Phase II trials, which have informed the dosage for an upcoming Phase III trial that is expected to be completed in 2025.  The first Phase II trial was a proof-of-concept study conducted in 2014 with 95 males with androgenetic alopecia. However, the Phase II trial results for male AGA were not publicly disclosed or published.^[13]Clinical Trials, (2017). A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males with Androgenetic Alopecia. Clinical Trials. … Continue reading

The second Phase II study was another proof-of-concept study for the use of CB-03-01 in the treatment of female pattern baldness. Once again, there have yet to be fully published results. However, Bloomberg did publish a press release summarizing the main findings.^[14]Cassiopea Spa, (2021). Cassiopea SpA Announces Topline Results of Phase II Proof of Concept Trial of Clascoterone Solution for the Treatment of Androgenetic Alopecia in Females. Bloomberg. Available … Continue reading. The trial enrolled 293 women aged 18 to 55, all experiencing androgenetic alopecia (AGA). The participants were divided into groups, with each group containing 70 individuals. The trial’s main objective was to evaluate the effects of different treatments over six months, comparing them to a control group that received a placebo (vehicle) and another group that used a 2% minoxidil solution.

All participants applied their assigned treatment twice daily. The treatment groups included two concentrations of CB-03-01, specifically 5% and 7.5%. The primary outcome measurements were changes in hair count and assessing hair growth over the six months of treatment.

Interestingly, only a subgroup of women under 30 using the 5% CB-03-01 solution showed statistically significant improvements in hair count, which was unexpected. Cassiopea mentioned that they were encouraged by the data and would further analyze it to identify further subgroups. However, since female-pattern hair loss typically occurs later in life for women (in their 50s or 60s), this treatment may not be appropriate for most patients. Therefore, further research is needed to determine its broader applicability.^[15]Fabbrocini, G., Cantelli, M., Masara, A., Annunziata, M.C., Marasca, C., Cacciapuoti, S. (2018). Female pattern hair loss: A clinical, pathophysiologic, and therapeutic review. International Journal … Continue reading 

Furthermore, although the press release mentioned that some participants were treated with 2% minoxidil, there was no information on how CB-03-01 performed compared to this. This highlights the issue of using press releases instead of peer-reviewed journal articles, as important data can be omitted.

The third phase II study recruited more than 400 male participants in Germany, aged 18-55, with mild to moderate AGA. All participants applied CB-03-01 at concentrations of 2.5%, 5%, 7.5% twice daily, or 7.5% once daily. The control group applied a  vehicle solution (once- or twice daily).^[16]Cassiopea Spa, (2021). Cassiopea Announces Very Positive Phase II Twelve Months Results for Breezula® (Clascoterone) in Treating Androgenetic Alopecia Bloomberg. Available at: … Continue reading Once again, the results were only available via a press release, so while some data was present we do not know if any has been omitted. It is reported that the results showed statistically significant improvements in target area hair counts and hair growth assessment scores across all active groups compared to the vehicle control. Notably, the highest change occurred in the 7.5% twice-daily group. This group also showed the highest statistically significant improvements in hair width in the treated area.

Two Phase III studies are awaiting recruitment, with expected completion dates in January 2025.^[17]Clinical Trials, (no date). CB-03-01. NIH. Available at: https://clinicaltrials.gov/search?cond=Hair%20Loss%2FBaldness&term=CB-03-01 (Accessed: 17 October 2023)

Is CB-03-01 Safe?

According to the Bloomberg press release, treatment-emergent adverse events (TEAEs) were mostly minimal, mild, or trace and unrelated to the study drug. However, very little detail is given. The most frequently observed local skin reactions across all treatment groups were minimal to mild scaling, redness, or minimal itching.^[18]Cassiopea Spa, (2021). Cassiopea SpA Announces Topline Results of Phase II Proof of Concept Trial of Clascoterone Solution for the Treatment of Androgenetic Alopecia in Females. Bloomberg. Available … Continue reading

In a Phase III trial of CB-03-01 for patients with facial acne, TEAEs were also generally mild in severity and similar to the control. The most common were pain, dryness, hypersensitivity at the site of application, redness, contact dermatitis, and headache.^[19]Hebert, A., Thiboutot, D., Gold, L.S., Cartwright, M., Gerlonim M., Fragasso, E., Mazzetti, A. (2020). Efficacy and Safety of Topical Clascoterone Cream, 1% for Treatment in Patients with Facial … Continue reading

CB-03-01 has yet to receive FDA approval for hair loss treatment, and certainly, more information on its safety and efficacy is required. The results from the upcoming Phase III studies should provide more information.

Can I Make CB-03-01 at Home?

We want to make it clear here – we do not endorse the use of homemade CB-03-01 (or any other treatment) as there may be issues with the purity of CB-03-01 and may lead to other unintended side effects. However, some people are buying powdered CB-03-01 and making a topical solution at home. CB-03-01 powder is widely available online for research and is easy to buy. As for a vehicle, some are using ethanol, propylene glycol (PG), and diethylene glycol monoethyl ether (DEGEE) at a 1:1:1 ratio, whereas others are using ethanol and PG alone.^[20]Reddit, (2020). Anyone know how to make your own CB0301 vehicle? Reddit. Available at: https://www.reddit.com/r/tressless/comments/l5y0di/anyone_know_how_to_make_your_own_cb0301_vehicle/ (Accessed: … Continue reading According to Selleckchem, it is soluble in both dimethylsulfoxide (DMSO) and ethanol.^[21]Selleckchem, (no date). Clascoterone. Selleckchem. Available at: https://www.selleckchem.com/datasheet/clascoterone-S689601-DataSheet.html (Accessed 17 October 2023)

Is CB-03-01 for Me?

While CB-03-01 is available under the brand name Winlevi for acne at a 1% concentration, it will not be available at the 5% dosage (which seemed effective in Phase II studies) until Phase III studies have been completed and FDA approval application has begun.

However, when it is available, you may want to try this treatment if:

• You are male or female 
• You are female and 30 or under
• You have AGA (this treatment targets androgen receptors, so it will not be beneficial for those with other types of hair loss)

 

Ketoconazole is used off-label to treat androgenic alopecia and telogen effluvium. While it is well-studied in men, there is a significant lack of clinical data showing its efficacy in women. In this guide, we will explore the evidence supporting the use of ketoconazole in androgenic alopecia, as well as answer whether it is suitable for use in women.

What is Ketoconazole?

Ketoconazole, primarily an antifungal drug, is commonly employed to combat diverse fungal infections within the body. Interestingly, it also finds application in addressing hair loss issues, including androgenic alopecia (AGA) and telogen effluvium (TE), typically through topical formulations and shampoos. Certain products containing ketoconazole for hair loss are accessible without a prescription, like shampoos containing 1% ketoconazole. Medical practitioners might advise or provide more potent ketoconazole treatments in specific cases.

Interested in Topical Minoxidil?

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*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

How Does Ketoconazole Work?

Ketoconazole functions as an antifungal agent by disrupting the cell membranes of fungi, impeding their growth and replication. Its antifungal properties are beneficial for addressing scalp conditions by reducing fungal activity and inflammation. In hair loss conditions like AGA and TE, ketoconazole contributes to a healthier and less inflamed scalp, creating a more conducive environment for growth.

Moreover, recent studies have suggested that ketoconazole shampoo may lower dihydrotestosterone (DHT) levels by inhibiting five alpha-reductases. Combined with treatments like finasteride, this can offer a more comprehensive approach to addressing these conditions.^[1]Perez, B.S.H. (2004). Ketoconazole as an adjunct to finasteride in treating androgenetic alopecia in men. Medical Hypotheses. 62(1). 112-115. Available at: … Continue reading

What Evidence is there for Ketoconazole in Hair Loss?

The effectiveness of ketoconazole in treating hair loss, particularly in conditions such as AGA and TE is supported by various clinical studies. These studies have explored the impact of ketoconazole not only as a standalone treatment but also in combination with other hair loss therapies.

Study One

This study involved 39 male participants exclusively with androgenic alopecia (AGA); the effects of 2% ketoconazole shampoo were compared to those of regular shampoo over 21 months. 27 men used the ketoconazole shampoo, while 12 used a regular shampoo. Additionally, 22 individuals without AGA served as controls, half using ketoconazole and the other half using regular shampoo. The results revealed a significant difference between the two groups.

Results

Among the non-AGA control participants, the choice of shampoo had no discernable impact on their AGA pilary index (defined as the product of the percentage of hairs in the growth (anagen) phase and average diameter (in micrometers) of the hair shaft).

Conversely, among the participants with AGA who used an unmedicated shampoo, there was a gradual linear decline in their AGA pilary index over time. In contrast, the group using the ketoconazole shampoo exhibited a progressive increase in their AGA pilary index, and this effect became noticeable after six months. The increase seemed to plateau after approximately 15 months of using the ketoconazole shampoo.^[2]Piérard-Franchimont, C., De Doncker, P., Cauwenbergh, G., Piérard, G.E. (1998). Ketoconazole shampoo: effect of long-term use in androgenic alopecia. Dermatology. 196(4). 474-477. Available at: … Continue reading

Study Two

Another study involved 150 male participants experiencing TE-related to AGA with associated dandruff. During the study, 150 male participants were split into three groups, and each group was given a different shampoo to use. One group used a shampoo containing 1% ketoconazole, another group used a shampoo with 1% piroctone olamine, and the third group used a shampoo with 1% zinc pyrithione.

The researchers measured hair shedding, hair density, the percentage of anagen (growth phase) hair, the average diameter of proximal hair shafts, and sebum excretion rates to evaluate the effectiveness of each shampoo.

Results

The study results indicated that all three shampoo formulations promptly addressed pruritus (itching) and dandruff symptoms, leading to rapid clearance. No significant changes were observed in any of the three shampoo groups regarding hair density.

However, there was a noteworthy reduction in all three groups regarding hair shedding. The ketoconazole group experienced a 17.3% decrease, the piroctone olamine group saw a 16.5% reduction, and the zinc pyrithione group had a 10.1% decrease in hair shedding.

Furthermore, the percentage of anagen hair increased in all three shampoo groups. The ketoconazole group exhibited a 4.9% rise, the piroctone olamine group showed a 7.9% increase, and the zinc pyrithione group demonstrated a 6.8% increase.

All groups showed a decrease in sebum secretion rates, with the ketoconazole group experiencing a 4.8% reduction, the piroctone olamine group showing a 2.9% decrease, and the zinc pyrithione group recording a 5.5% decline.^[3]Piérard-Franchimont, C., Goffin, V., Henry, F., Uhoda, I., Braham, C., Piérard, G.E. (2002). Nudging hair shedding by antidandruff shampoos. A comparison of 1% ketoconazole, 1% piroctone olamine, … Continue reading

Other Studies

Two other studies evaluated the efficacy of ketoconazole in combination with other hair loss treatments like finasteride and minoxidil in men with AGA. They found it works well as a combination therapy and can even improve AGA in men with atopic and/or seborrheic dermatitis.

So, clinical evidence shows that ketoconazole can improve hair loss outcomes. However, all these studies suffer from a significant limitation; they have only included male subjects. Let’s find out if there is evidence for using ketoconazole in women.

Clinical Evidence for Ketoconazole for Women

There is currently no published evidence for using ketoconazole shampoo in women. However, one study did compare the efficacy of a 2% ketoconazole solution to 2% minoxidil in female pattern hair loss. The study involved 40 female pattern hair loss patients. 20 were in Group A using 2% topical minoxidil, and 20 were in Group B treated with 2% topical ketoconazole. Both groups received treatment for six months, with changes to the Ludwig scale and trichoscopic (magnified images of the scalp, typically used for counting hairs) outcomes evaluated.

Results

The results showed that both groups experienced improved hair growth (Figure 1 & 2), but the minoxidil group responded faster. In contrast, the ketoconazole group had a delayed response, which became significant at the 6-month. Side effects were also less common in the ketoconazole group (10% vs. 55% in the minoxidil group), and patient satisfaction did not significantly differ between the two groups.^[4]El-Garf, A., Mohie, M., Salah, E. (2019). Trichogenic effect of topical ketoconazole versus minoxidil 2% in female pattern hair loss: a clinical and trichoscopic evaluation. Biomed Dermatol. 3(8). … Continue reading

 

 

The study indicates that applying ketoconazole topically can facilitate hair regrowth in women with fewer side effects than minoxidil. Ketoconazole is probably as effective for women as it is for men. However, additional research is necessary to obtain a more comprehensive understanding of its efficacy and safety.

Can I Use Ketoconazole If I am Pregnant or Breastfeeding?

We always recommend a trip to the doctor before using any product if you are pregnant or breastfeeding. While certain patient informational leaflets suggest ketoconazole shampoo can be used during pregnancy and breastfeeding, the ketoconazole dilutions in those leaflets only reference products with 20 mg per gram of ketoconazole.^[7]Nizoral, (no date). Nizoral Anti-Dandruff Shampoo Ketoconazole. Nizoral. Available at: https://www.medicines.org.uk/emc/files/pil.6456.pdf (Accessed: 03 November 2023) Be sure to check with your doctor to confirm your dilution of ketoconazole shampoo matches that of 20 mg/gram, and that your doctor also agrees with these recommendations.

Can I Use Ketoconazole Alongside Other Hair Loss Medications?

Researchers have observed that combining ketoconazole with other treatments works best in treating AGA in humans. This is because ketoconazole has different mechanisms of action than minoxidil, microneedling, and finasteride. Targeting multiple mechanisms generally leads to better results. If you’re interested in seeing a real-life example of hair regrowth achieved using ketoconazole in combination with other treatments, you can find it here.

Hair Shedding

Understanding the reasons behind hair shedding is important when using ketoconazole shampoo, as it helps in distinguishing between normal hair loss and the potential side effects of the treatments. Various factors can influence hair shedding, and it’s important to identify whether this shedding is (1) a positive shed in response to starting ketoconazole, (2) a reaction to the ketoconazole itself, and/or (3) if this hair shedding is actually coincidental to your introduction of ketoconazole, and is instead caused by other factors: seasonal hair cycling, the introduction or withdrawal of other hair loss treatments, and/or telogen effluvium sheds.

Medical and legal consensus – with any treatment-related side effect – is to stop that treatment and consult with your doctor immediately. Nonetheless, we’ll go through a few of these situations below, along with potential troubleshooting advice for resolution:

Scalp Issues

If your hair shedding is accompanied by scalp dryness, hair dryness, and/or itchiness, then this might be a reaction from the ketoconazole shampoo, and you can follow the above-mentioned measures to mitigate the side effects.

If your hair shedding is accompanied by scalp redness, then there is a slight possibility that you are having a very rare allergic reaction to the shampoo. In cases like this, we recommend stopping the ketoconazole and seeing a doctor or dermatologist who can further assess your tolerability. While allergic reactions to ketoconazole are rare, it is usually best to err on the side of caution – especially as ketoconazole tends to be a lower-leverage treatment option (meaning that it often does not produce vast amounts of hair regrowth).

Scalp Adjustment to Treatment

If any other side effects do not accompany your hair shedding and you have just started ketoconazole in the last 3 months, then it may just be that your scalp is still adjusting (and responding) to new treatments. Therefore, it might be that some of your shedding is due to a positive treatment response. We’ll have more articles about this soon.

Seasonal Shedding

Sometimes, increases to hair shedding have nothing to do with your hair loss treatments and, instead, are simply a function of seasonal hair shedding.

Humans undergo a temporary uptick in shedding due to hair cycle seasonality. In the northern hemisphere, these upticks typically occur in July and August, then settle into lower shedding rates in winter. While this shedding is mostly unavoidable, there’s also good news: it doesn’t really interfere with the success of your long-term hair loss treatments. So, if you’re within peak windows of time for seasonal hair shedding, you may want to consider that at least some of this shedding might not be due to ketoconazole, but instead, due to seasonality.

Recent Introduction/Withdrawal of Other Treatments

It may also be that the hair shedding might not be related to ketoconazole use. If you have withdrawn from or introduced other hair loss treatments within the last three months, these changes may also explain recent upticks to hair shedding.

Skin Burning, Peeling, or Redness

As mentioned above, scalp redness has a slight possibility of being a rare allergic reaction to the shampoo. We recommend stopping using the shampoo and seeing your doctor or dermatologist for advice.

Hair Discoloration

Hair discoloration is a rarer side effect of ketoconazole shampoo, but a few long-term treatment users have reported it. Under these circumstances, we recommend you stop using ketoconazole shampoo and instead switch to other shampoos with anti-dandruff and antifungal properties, but that work through different mechanisms and thus may not evoke the same effect. Consider shampoos with the following active ingredients: selenium sulfide and/or zinc pyrithione.

Shampoos with these ingredients are widely sold over the counter and are specifically formulated to reduce dandruff and skin flaking. There’s also some evidence that they may support hair growth in those with androgenic alopecia, female pattern hair loss, and/or telogen effluvium associated with microorganism overgrowths.^[3]Trueb, R.M., Henry, J.P., Davis, M.G., Schwartz, J.R. (2018). Scalp Condition Impacts Hair Growth and Retention via Oxidative Stress. International Journal of Trichology. 10(6), 262-270. Available … Continue reading,^[4]McGinley, K.J., Leyden, J.J. (1982). Antifungal activity of dermatological shampoos. Archives of Dermatological Research. 272(3-4). 339-342. Available at: https://doi.org/10.1007/BF00509065

Other Side Effects

If you experience any other side effects and want advice from the community, feel free to make a forum post describing your growth regimen, ketoconazole shampoo routine, and specific side effects. Our team and community will chime in with resources and strategies to help you resolve this. You can post your questions here.

Corticosteroids are a class of steroid hormones that have emerged as a treatment against, in particular, alopecia areata and scarring alopecia. These compounds, synthesized to mimic the activity of cortisol, a hormone produced by the adrenal glands, exhibit potent anti-inflammatory and immunosuppressive properties. This makes them effective in treating hair loss conditions where inflammation or an autoimmune response plays a critical role.

However, long-term corticosteroid use is not without potential drawbacks. When overused (or used for too long), topical corticosteroids are causally linked to hormonal changes, alterations to skin pigmentation, the creation of spider veins, and even skin thinning. Some adverse effects can be permanent – with the risk of irreversibility increasing alongside the dose and duration of use. Without usage breaks and/or careful dosing guidelines, long-term users of topical corticosteroids can inadvertently disfigure their skin.

In the last two years, we’ve observed a concerning trend in the hair loss industry: big-brand telehealth companies now add low-dose corticosteroids – i.e., 1% hydrocortisone and 0.01% fluocinolone – to their prescription hair growth topicals. They’re also recommending patients apply corticosteroids to their scalps up to twice daily, forever.
These corticosteroids undoubtedly help lower scalp inflammation and may offset skin irritation from ingredients like tretinoin (retinoic acid) – which is often paired with hair growth drugs, such as minoxidil, to enhance drug activation and penetration.

But is there any evidence that twice-daily use of topical corticosteroids – applied daily, forever, and with no pulse dosing or dosing breaks – is safe? Or are these telehealth companies exposing their patients to unknown risks, gambling with their health, and selling them into short-term hair gains without considering the long-term consequences?

This article will delve into the efficacy and long-term safety of corticosteroids – particularly as a therapy for hair loss disorders. We’ll explore corticosteroids and their therapeutic role in treating hair loss. We’ll also explore considerations for dosing and duration. This is particularly important for people who might be currently using topical corticosteroids on their scalps and who don’t understand the risks they might be exposing themselves to 5-10 years into the future.

Interested in Topical Finasteride?

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*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

What Role Do Corticosteroids Play in Treating Alopecia?

In the context of alopecia, corticosteroids reduce inflammation and suppress the immune system’s activity around hair follicles. This action can halt the progression of hair loss and, in many cases, stimulate hair regrowth. The application of corticosteroids in hair loss treatment can vary; they can be administered topically, injected directly into the scalp, or taken orally. 

Within the class of corticosteroids are:

Glucocorticoids: such as cortisol and cortisone, influence carbohydrate, fat, and protein metabolism.^[1]Macfarlane, D.P., Forbes, S., Walker, B.R. (2008). Glucocorticoids and fatty acid metabolism in humans: fuelling fat redistribution in the metabolic syndrome. Journal of Endocrinology. 197(2), … Continue reading They are anti-inflammatory, immunosuppressive, and vasoconstrictive (narrow blood vessels). Their anti-inflammatory effects occur through inhibiting inflammatory mediators and stimulating anti-inflammatory mediators. Their immunosuppressive effects occur through direct action on immune cells.^[2]Coutinho, A.E., Chapman, K.E. (2011). The anti-inflammatory and immunosuppressive effects of glucocorticoids, recent developments, and mechanistic insights. Molecular and Cellular Endocrinology. … Continue reading 

Mineralocorticoids: such as aldosterone, regulate electrolyte and water balance. They modulate ion transport in the renal tubules of the kidneys.^[3]Yang, J., Young, M.J. (2009). The mineralocorticoid receptor and its coregulators. Journal of Molecular Endocrinology. 43(2), 53-64. Available at: https://doi.org/10.1677/JME-09-0031

How is the Potency of a Corticosteroid Decided?

There are seven potency classifications for corticosteroids, which range from Class I – super potent corticosteroids to Class VII – least potent corticosteroids.^[4]Gabros, S., Nessel, T.A., Zito, P.M. (2023) Topical Corticosteroids. In: StatPearls [Internet]. Treasure Island (FL):  StatPearls Publishing. Available from: … Continue reading This is based on several factors, including its chemical structure, formulation, and the ability of the drug to cause vasoconstriction in the skin, which is often assessed through vasoconstrictor assays.^[5]Stoughton, R.B. (1992). The vasoconstrictor assay in bioequivalence testing: practical concerns and recent developments. International Journal of Dermatology. Available at: … Continue reading These assays measure the degree of skin blanching (induction of longer-than-normal skin paleness) induced by the corticosteroid. 

What are the Benefits of Corticosteroids in Treating Alopecia?

Corticosteroids are particularly beneficial in treating alopecia areata and scarring alopecias because they modulate inflammatory and immune response pathways. High potency, medium potency, and low potency have all shown some efficacy in treating alopecia, with the highest efficacy observed with high-potency corticosteroids under occlusion.^[6]Alsantali, A. (2011). Alopecia areata: a new treatment plan. Clinical Cosmetic and Investigational Dermatology. 4, 107-115. Available at: https://doi.org/10.2147/CCID.S22767 

However, it should be noted that their maximum usage durations depend on the potency of the corticosteroid. Super potent corticosteroids have a maximum duration of 3 weeks, high and medium potency have a maximum duration of 12 weeks, and low potency have no specified limit.^[7]Stacey, S.K., Mceleney, M. (2021). Topical Corticosteroids: Choice and Application. American Family Physician. 103(6). 337-343. Available at: … Continue reading Continuing to use corticosteroids after these time points may increase the risk of experiencing adverse effects.

What Risks Are Associated with Corticosteroid Use?

Topical corticosteroids can lead to both skin-related (cutaneous) and whole-body (systemic) side effects, with risk increasing with a larger area of application and higher potency of the drug.^[8]Stacey, S.K., Mceleney, M. (2021). Topical Corticosteroids: Choice and Application. American Family Physician. 103(6). 337-343. Available at: … Continue reading 

Some common skin-related effects can include:

• Skin thinning
• Stretch marks
• Spider veins
• Easy bruising and purpura
• Delayed wound healing 
• Hyper or hypopigmentation
• Acne and rosacea like eruptions
• Hypertrichosis (increased hair growth)
• Infections or aggravation of existing infections

Long-term use may lead to whole-body (systemic) effects. These can include:

• Hypothalamus-pituitary-adrenal activity suppression (characterized by weakened immunity, anxiety, midday fatigue, difficulty sleeping, depression, and aching joints, amongst others)
• Cushingoid appearance (moon face, acne, and thin, easily bruised skin, amongst others)
• Unwanted facial skin hair in women (hirsutism) 
• Impotence
• Menstrual irregularities
• Peptic ulcer disease
• Cataracts
• Increased intraocular pressure/glaucoma
• Myopathy
• Osteoporosis
• Vertebral compression fractures​

Some patients may also experience a rebound phenomenon – although this is rare in low-potency corticosteroids.

One case study shows a patient who experienced worsening rebound after being treated with first 0.5%, then 1% of hydrocortisone, and again after a 5-day course of clobetasol butyrate and then hydrocortisone.^[9]MEDSAFE, (2013). Steroid Rebound – A Topical Issue. MEDSAFE. Available at: https://www.medsafe.govt.nz/profs/PUArticles/June2013Steroid.htm (Accessed: 12 January 2023) It only resolved 3.5 months after stopping all steroid treatments.

However, a retrospective study of 300 patients found that patients who had received hydrocortisone 0.75% and precipitated sulfur 0.5% lotion for up to 15 years for common dermatological conditions of the face showed no evidence of rebound phenomenon, steroid acne, and perioral dermatitis.^[10]Harlan, S.L. (2008). Steroid acne and rebound phenomenon. Journal of Drugs in Dermatology. 7(6). 547-550. Available at: PMID:18561585

What are the Long-Term Effects and Safety Profiles of Low Potency Corticosteroids?

There is no specified limit on the duration of use of low-potency corticosteroids. But how safe are they really? Are there any long-term studies showing that these steroids are safe to use long-term?

We’ve collated the longest studies available for several low-potency corticosteroids to help us determine this.

Corticosteroid	Study: alopecia	Study: other indication	Safety profile (adverse effects?)	References
Alclometasone dipropionate 0.05%	N/A	Applied twice daily for 21 days in 31 patients with psoriasis. A comparative study with clobetasone butyrate cream 0.5%.	No reported adverse events.	[11]Aggerwal, A., Maddin, S. (1982). Alclometasone Dipropionate in Psoriasis: A Clinical Study. Journal of International Medical Research. 10, 414-418. Available at: … Continue reading
Desonide 0.05%	N/A	Twice daily application of either desonide 0.05% hydrogel or desonide 0.05% ointment in 46 patients with mild to moderate atopic dermatitis. The study length was 4 weeks.	No reported adverse events.	[12]Trookman, N.S., Rizer, R.L. (2011). Randomized Controlled Trial of Desonide Hydrogel 0.05% versus Desonide Ointment 0.05% in the Treatment of Mild-to-moderate Atopic Dermatitis. The Journal of … Continue reading
Fluocinolone acetonide 0.01%	N/A	Once daily application for 12 months alongside hydroquinone 4% and tretinoin 0.05% in 228 patients for treating facial melasma.	Six cases of telangiectasia (spider veins), 5 mild and 1 moderate.	[13]Torok, H.M., Jones, T., Rich, P., Smith, S., Tschen, E. (2005). Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: a safe and efficacious 12-month treatment for melasma. Cutis. 75(1), … Continue reading
Hydrocortisone 1%	Applied twice daily to areas of hair loss for 2 cycles of 6 weeks on and 6 weeks off for a total of 24 weeks. 42 children with alopecia areata. Hydrocortisone 1% compared to clobetasol propionate 0.05%.	Twice daily application of either hydrocortisone 1% or desonide 0.05% for 5 weeks in 113 children with mild-to-moderate atopic dermatitis. 36 children continued the study through to 6 months.	Alopecia study: 2 patients in the hydrocortisone group experienced abnormal cortisol levels, which were resolved by the end of the study. One patient showed skin atrophy, which resolved by week 6.	[14]Lenane, P., Macarthur, C., Parkin, C.P., Krafchik, B., DeGroot, J., Khambalia, A., Pope, E. (2014). Clobetasol Propionate, 0.05%, vs. Hydrocortisone, 1% for Alopecia Areata in Children. A Randomized … Continue reading,[15]Jorizzo, J., Levy, M., Lucky, A., Shavin, J., Goldberg, G., Dunlap, F., Hinds, A., Strelka, L., Baker, M., Tuley, M., Czernielewski, J.M. (1995). Multicenter trial for long-term safety and efficacy … Continue reading,[16]Salava, A., Perala, M., Pelkonen, A.S., Remitz, A., Makela. (2022). Safety of tacrolimus 0.03% and 0.1% ointments in young children with atopic dermatitis: a 36-month follow-up study. Clinical and … Continue reading,[17]Sigurgeirsson, B., Boznanski, A., Todd, G., Vertruyen, A., Schuttelaar, M.L.A., Zhu, X., Schauer, U., Qaqundah, P., Poulin, Y., Kristjansson, S., von Berg, A., Nieto, A., Boguniewicz, M., Paller, … Continue reading
		Twice daily application of 1. Hydrocortisone 1% or, if needed, hydrocortisone-17-butyrate or 2. 0.03% tacrolimus ointment for a 3-7 day course until clearance was achieved in 152 young children (aged 1-3) with eczema. 3 year follow-up.	No side effects were observed for the hydrocortisone group.
		Application (not mentioned how often) of either pimecrolimus or 1% hydrocortisone in 2418 infants with atopic dermatitis. The treatment was used at the first signs/symptoms until clearance and initiated at the first signs/symptoms of atopic dermatitis. 5-year follow-up.	1% hydrocortisone was associated with an increased incidence of fever, cough, pharyngitis, viral rash, and lower respiratory tract infection.

A number of the corticosteroids did not have any studies conducted for alopecia areata. Furthermore, several studies did not report any side effects; however, the corticosteroids were only used for 21 – 28 days in these cases. The study using fluocinolone 0.01% was the longest and was used daily for one year, with few side effects, which is promising.^[18]Torok, H.M., Jones, T., Rich, P., Smith, S., Tschen, E. (2005). Hydroquinone 4%, tretinoin 0.05%, fluocinolone acetonide 0.01%: a safe and efficacious 12-month treatment for melasma. Cutis. 75(1), … Continue reading However, the researchers claimed that there were no signs of skin atrophy or thinning, but 6 patients did experience telangiectasia (otherwise known as spider veins) – which incidentally is a sign of skin thinning.^[19]Mount Sinai, (no date), Telangiectasia. Mount Sinai. Available at: … Continue reading

The only study that used a low-potency corticosteroid to treat alopecia areata was hydrocortisone 1%. In this study, participants applied hydrocortisone 1% or clobetasol propionate 0.05% twice daily to areas of hair loss for 2 cycles of 6 weeks on and 6 weeks off for 24 weeks. During this time, there were few adverse events reported. These were abnormal cortisol levels, which were resolved before the end of the study. Furthermore,  one patient who had extensive alopecia areata showed skin atrophy, which resolved by itself in 6 weeks.^[20]Lenane, P., Macarthur, C., Parkin, C.P., Krafchik, B., DeGroot, J., Khambalia, A., Pope, E. (2014). Clobetasol Propionate, 0.05%, vs. Hydrocortisone, 1% for Alopecia Areata in Children. A Randomized … Continue reading 

Furthermore, the only two studies that did include long-term follow-up either used very short pulses of the topical corticosteroid treatment or didn’t mention how often it was used at all.

It is clear from the above table that there is a distinct lack of long-term safety data for the use of corticosteroids in dermatological conditions and hair loss conditions. However, short-term or pulsed use (in the case of hydrocortisone) showed very few, if any, adverse effects.

What Role Do Telehealth Companies Play in The Sale and Use of Corticosteroid Treatments?

Telehealth companies provide a convenient alternative to accessing personalized medication and specialized knowledge that may not be readily available in general practice. Furthermore, you can do this from home, eliminating the need for travel and spending time in waiting rooms. You can buy compounded medications from these companies, including mixtures of finasteride, minoxidil, retinoids, and corticosteroids, amongst other treatments. 

However, it appears that some telehealth companies may not be providing enough information for the typical buyer to determine how often they should be using their products that contain corticosteroids.

Some of these companies are also burying the known safety concerns of low-potency corticosteroids deep within their website navigations, while also not clearly stating these concerns upfront to prospective consumers. This strategy might help to mitigate these companies from legal actions related to non-disclosures, while at the same time, not truly informing their customers of the very real (and uncertain) risks they may face 2, 3, or 5 years into the future while using their products.

Conclusion

Short-term or pulsed use of low-potency corticosteroids might be safe and effective for hair loss conditions such as alopecia areata. However, the long-term safety of these treatments is less clear, with a distinct lack of extensive, long-term studies. The risks of long-term corticosteroid use are well-documented, which underscores the importance of careful monitoring and following medical guidance when using these treatments. While telehealth companies offer convenience and access to a range of hair loss treatments, including those containing corticosteroids, there is a gap in providing comprehensive safety information and use guidelines that align with the currently available data. This lack of information raises concerns about the potential for overuse or misuse of these products.

Finasteride is an FDA-approved medication for androgenic hair loss in men. Clinical studies suggest that 1 mg daily of finasteride can improve hair loss in 80-90% of men with androgenic alopecia (AGA) – with 5- and 10-year studies demonstrating hair maintenance in a large portion of users who continue treatment. 

As such, many consider finasteride to be the gold-standard medical therapy for AGA. 

But what happens when someone stops using finasteride? How long are hair gains preserved? When does hair loss resume? And can someone quit finasteride, but keep their hair gains by replacing finasteride with other treatments and/or therapies? 

This article explores some of the studies attempting to answer these questions.^[1]https://pubmed.ncbi.nlm.nih.gov/9777765/^[2]https://pubmed.ncbi.nlm.nih.gov/11809594/^[3]https://www.oatext.com/Long-term-(10-year)-efficacy-of-finasteride-in-523-Japanese-men-with-androgenetic-alopecia.php

Interested in Oral Finasteride?

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What Happens If I Stop Using Finasteride?

Package inserts for the drug Propecia® (brandname finasteride) suggest that within 3-12 months of quitting finasteride, hair loss resumes and hair counts return to where they were prior to starting the drug.

But what’s the basis for this statement? In other words, where’s the scientific support?

The evidence actually comes from the original Phase II and Phase III clinical trials that granted finasteride FDA-approval for the treatment of androgenic alopecia.^[4]https://pubmed.ncbi.nlm.nih.gov/9777765/

In a subset of finasteride users, participants were given the drug for a full year, then unknowingly switched into the placebo (i.e., sugar pill) group for the second year (i.e., months 12-24).

The investigators then charted these participants’ hair count changes from months 0-24, and compared those changes to those who continued using finasteride and those who were always receiving the placebo pill.

The results: unknowingly quitting finasteride led to a return to month 0 hair counts (actually, slightly below baseline) after 12 months of discontinuance. Just see the following chart. The group labeled Fin→Pbo is the group who took finasteride for year one, and a placebo pill for year two.

This chart provides the scientific backing for the claims made within the Propecia® package insert. It’s also the reason why manufacturers of finasteride state that the drug must be used for a lifetime in order to maintain any of the hair gained and/or preserved by the drug.

What If I Stop Taking Finasteride Temporarily?

Under some circumstances, it is possible to stop taking finasteride temporarily, and without losing much (or any) hair. This is because there is a delay between the time at which finasteride is discontinued and when hair loss resumes.

The reason for this delay is because of the way finasteride behaves in the body – i.e., the drug’s pharmacokinetics. More specifically, finasteride’s metabolism and timing of effects on the body depend on factors such as its:

• Terminal half-life
• Biological half-life
• Tissue dissociation timings

For a deep-dive into these topics, see these articles.

• Finasteride: How Long Does It Stay In The Bloodstream?
• Finasteride: How Long Does It Stay Active In Scalp Tissue?

Otherwise, here are the key takeaways:

1. Finasteride’s biological effects can last up to 30 days after quitting

Due to finasteride’s terminal half-life of 5-7 hours and tissue dissociation timing of 4-5 days, the drug can actually exert biological effects on hormone profiles even up to ~30 days after quitting.

That means that finasteride can continue to therapeutically lower scalp levels of dihydrotestosterone (DHT), even for weeks after quitting the medication.

Just see this chart, which shows that even after men quit using finasteride, it still took several weeks before their serum DHT levels returned to baseline.^[5]https://academic.oup.com/jcem/article/89/5/2179/2844345

(Note: these relationships assume that finasteride reachced full tissue distribution and a steady-state plasma level commensurate with 1-5 mg of daily use over a number of weeks. For those who only took finasteride a handful of times, the drug’s effects may only take a matter of days to reverse).

2. Users can take advantage of the pharmacokinetics of finasteride to reduce drug exposure and still preserve their hair gains

Finasteride is FDA-approved for androgenic alopecia at 1 mg daily doses. However, given the pharmacokinetics of the drug, some researchers have wondered if daily dosing is necessary.

One investigation group decided to explore this by putting a group of men on 1 mg of finasteride daily for a year. But for year two, they randomized the men into two groups: one group who would continue taking finasteride every day, and the other group who would start a 30 days-on, 30 days-off dosing approach.

The researchers found that both groups achieved comparable hair parameter improvements in year two – even despite the second group only technically using finasteride for half the time (i.e., a total of 6 months versus 12 months).^[6]https://jaad.org/retrieve/pii/S0190962220319289

The hypothesis: that finasteride’s pharmacokinetics allow for dosing schedules that alternate month-to-month. For those wanting to lower their drug exposure or simply “take breaks” from the medication – for any reason – this type of dosing might allow for this to happen without sacrificing much (or any) hair gains.

What If I Stop Finasteride For Longer Than One Month?

Say you’re troubleshooting side effects, or trying to conceive, and you decide to pause your use of finasteride for longer than one month.

Under these circumstances, there is a higher likelihood of hair loss resuming versus the 30-day withdrawal window. We see this reflected clinically in the withdrawal studies on finasteride, as well as anecdotally amongst members of our membership community.

This is because after 30 days of withdrawal, the effects of finasteride on scalp DHT levels have mostly worn off. This means that scalp DHT levels return to baseline, and under these circumstances, hair loss will eventually resume.

However, for many people, the resumption of hair loss doesn’t happen immediately. While there aren’t any studies of which we’re aware that track finasteride withdrawal versus hair count changes on a month-by-month basis, we have communicated with many finasteride users who’ve consistently reported, after quitting, that hair shedding and hair loss didn’t seem to pick back up again until months 2, 3, and beyond.

Even still, if you’re considering pausing finasteride use for any reason, try to keep the window of time beyond 30 days to a minimum. In doing so, you’ll put yourself in the best possible position for drug-related hair maintenance.

What If I Quit Finasteride And Replace It With Other Treatments?

We get this question all the time, and unfortunately, there’s no good clinical data to answer this question.

Scientifically speaking, finasteride’s mechanism of action is that it suppresses scalp DHT levels low enough to allow for hair cycle normalization and the partial reversal of hair follicle miniaturization. This typically occurs only at therapeutic levels of DHT reduction, which according to clinical studies for hair regrowth, seem to require lowering scalp DHT by 60-70%.

If someone quits finasteride and replaces the drug with other treatments, the preservation of any hair gains from finasteride will, for the most part, directly depend on the ability for those “replacement treatments” to suppress DHT levels to the same degree of finasteride.

For better or for worse, finasteride is one of the best tools we have to therapeutically and safely suppress scalp DHT levels enough to generate long-lasting hair growth – even despite its risk of side effects, which seem to affect 5-15% of users trying the drug.

Therefore, for anyone considering quitting finasteride, the most important question is to understand why. Then, we can create a roadmap or action plan based on that answer. For example:

• If quitting finasteride (as a male) to start to conceive: this can be done temporarily, and without a high risk of hair loss provided that you can conceive after month one of quitting but before month three of discontinuance.
• If quitting finasteride due to side effects: there’s a good chance that those side effects can be managed or eliminated with dose titration strategies, and/or the use of topical finasteride.
• If quitting finasteride because you want to try a natural approach to treating hair loss: we recommend first adding in a natural approach alongside finasteride use, rather than quitting finasteride abruptly.
• If quitting finasteride because you no longer want to use drugs to treat hair loss: we recommend watching this video to ensure your decision isn’t rooted in cognitive dissonance or misinformation.

If quitting finasteride for any other reason, please note that there are no studies exploring outcomes for men or women who withdraw from finasteride and replace the drug with other treatments.

Having said that, the totality of evidence strongly suggests that this is not necessarily a good gamble to make – as finasteride tends to suppress DHT levels in the scalp by a far larger margin (and for a far longer time period) than natural extracts such as saw palmetto. So, your expectation should be that hair loss, in all likelihood, will slowly resume.

Even still, we have seen success stories of people transitioning off finasteride and maintaining their hair gains. While this isn’t an approach we recommend unless absolutely necessary, here are the commonalities amongst people who’ve reported success with this:

1. They multi-target their hair loss. In other words, they replace finasteride use with an array of supplements, topicals, and stimulation-based interventions that target their hair loss from multiple angles: DHT reduction, growth stimulation, angiogenesis, and more.
2. They don’t immediately withdraw from finasteride. Instead, they add in all replacement interventions alongside finasteride use – and for at least 9-12 months. This allows for any potential synergies to occur between finasteride use and other therapies. Then, after achieving a new level of hair regrowth, they slowly wean away from finasteride via strategies such as topical finasteride and every-other-month oral dosing followed by titration – until after 3-5 months, they’re no longer using finasteride at all. Under the circumstances where users start noticing more hair fall, they hop back on finasteride until things stabilize. Under the circumstances whereby hair gains are maintained, they continue their drug withdrawal.

To reiterate, this is not something we actively recommend. But for those considering doing this, we recommend the above two strategies to minimize your downside risks.

Want Help With Your Hair Loss?

We offer one-on-one support to hair loss sufferers inside our membership community. This is where you can interact directly with hair loss researchers, access our library of product reviews, use our automated tools to build yourself a personalized regrowth plan, and protect yourself from the overwhelming negativity of most online hair loss forums.

If you’re interested in learning more, you can access our membership community right here.

Otherwise, we hope this article helps you make more informed decisions about your treatment choices.

In this article, we’ll explore the science behind topical finasteride, if incidental exposure to the drug comes with a risk of harming pregnant women and/or children, and strategies you can employ starting today to minimize inadvertently exposing your household to secondary finasteride exposure – all while still preserving your hair gains from the drug.

Topical Finasteride: Benefits & Drawbacks

Finasteride is the world’s most effective FDA-approved treatment for androgenic alopecia in men. Having said that, the drug is not safe for use in children or in pregnant woman – mainly because it inhibits an enzyme that is critical for proper fetal and adolescent development.

Oral formulations of finasteride are ingested by the user, and thereby eliminate almost all possibilities of incidental drug exposure to partners or other household members of the drug user. The only exception to this is a small amount of detectable finasteride in semen, which can be absorbed by a partner during periods of unprotected intercourse – and in amounts that are considered far below danger levels (even while pregnant).^[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2018472/pdf/11785276.pdf

In recent years, interest has exploded in an alternative delivery vehicle for finasteride: topical finasteride. This is because preliminary studies suggest topical finasteride can confer similar hair improvements versus the oral formulations, but also better localize the effects of the drug mainly to the scalp – thus lowering the risk of finasteride’s side effects.

Having said that, the switch to topical formulations comes alongside new risks: incidental drug exposure to partners and other members of the household. But are these risks quantifiable, and if so, how can we reduce them?

Interested in Topical Finasteride?

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*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

How Might Incidental Exposure To Finasteride Occur?

After applying topical finasteride, there is often a period of time – up to 30 minutes – whereby that finasteride solution has yet to fully dry onto the scalp. During this period, it’s much easier for topical finasteride to find its way onto other household surfaces or people – particularly if contact is made with the scalp.

During this window of time (when topical finasteride isn’t yet fully dried), here a few ways inadvertent exposure to topical finasteride can occur:

1. Putting your head down on a pillowcase, thereby rubbing residual finasteride onto sheets that might be shared with your partner and/or children
2. Resting your head on couch pillows and/or furniture surfaces
3. Letting your partner and/or children play with your hair

In all of these scenarios, the amount of exposure to a partner or child will be relatively small. However, with repeated daily exposure throughout critical periods of development – such as a partner’s pregnancy or a child’s adolescence – each repeated contact comes alongside a cumulative increased risk of adverse events.

While the long-term effects of repeated, residual contact by spouses and/or children from topical finasteride have not been thoroughly investigated – and likely never will be (due to the difficulties of conducting such a study) – it goes without saying that it’s within our best interests not to expose our loved ones to unnecessary risks, particularly those that come with the potential for long-long adverse effects.

Topical Finasteride: How To Minimize Incidental Exposure To Loved Ones

Fortunately, when it comes to topical finasteride, there are great science-based management strategies that should allow you to keep using the medication while also minimizing – or even eliminating – your loved ones’ risks of incidental exposure. Here are a few that might take most of the risk off the table.

1. After applying topical finasteride, avoid physical contact for ~30 minutes

Depending on the carrier agents used for topical finasteride (alcohol, propylene glycol, etc.), most topicals should fully dry within a 30-minute window after application. At this point, most of the topical finasteride will remain trapped within the dried portion of the topical.

Once this window is reached, it’s far less likely that scalp contact with pillow cases, furniture, or even a partner’s hands will lead to appreciable leeching off the scalp. So, by making this very simple change, men and women can perhaps take most of the risk away regarding incidental finasteride exposure.

2. Wash pillow cases regularly, and try to dedicate a pillowcase just for the user of finasteride

Even after letting the topical dry, some topical finasteride (albeit significantly less) will leech onto the pillowcase or wherever else you might rest your head. While the amount will be substantially smaller than if you were to rest your hand on that pillowcase before the 30-minute time window for drying is completed, there’s still some topical finasteride that will end up in those sheets.

Under these circumstances, weekly washing of pillowcases is warranted. If that’s not of interest to you or your partner, you can instead dedicate one pillowcase to the person using topical finasteride that the other partner will not use.

If that’s not enough to create peace-of-mind, you can also consider wearing a loosely-fitting shower cap to bed. Some members of our membership community do this – particularly fathers with young boys who don’t want to leave any incidental exposure risks to chance.

3. Time your application windows for when you are out-of-the-house and/or unlikely to have skin contact with household members

Topical finasteride users can dramatically reduce the cumulative exposure risk to loved ones by timing their topical applications to periods where they are (mostly) outside of the home and/or unlikely to come into skin-to-skin contact with other household members. This can be done by either:

1. Applying topical finasteride at least 30 minutes before bed, then washing it out each morning
2. Applying topical finasteride prior to leaving for work, then washing it out after arriving home

If opting for either strategy, it’s critical to let topical finasteride site in the scalp skin for at least 6-12 hours. Otherwise, the diminishment in the drug’s contact time in the scalp may begin to hinder its efficacy. Here’s why.

How Long Should Topical Finasteride Stay on the Scalp Before Washing It Out?

When topicals are applied to the skin, there are multiple stages of absorption.

• Stage #1: the drug sits on the epidermis (the outermost layer of skin). Over several hours, some of the drug will absorb into the dermis, and some will evaporate.
• Stage #2: the drug absorbs percutaneously. This is when some of the drug moves from the epidermis into the dermis, where it can begin to affect hair follicles.
• Stage #3: the drug absorbs systemically. This is when some of the drug moves from the dermis into the bloodstream, where it can have systemic effects.

So, what’s the minimum amount of time topical finasteride must be left on the scalp to have an effect? First, one needs to know how much of the drug absorbs into the dermis over time.

To answer this, there is an in vitro study measuring percutaneous absorption of topical finasteride across various formulations: ethosomes, ethanol, liposomes, and aqueous (water). ^[2]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2977015/

Here’s a chart showing the percent of topical finasteride that percutaneously absorbs (enters the dermis) over a 24-hour period:

According to these study results, if applying hydroethanolic finasteride to the scalp, then at the 10-hour mark, ~5 ug/cm² will have been absorbed percutaneously. By hours 22-24, that absorption rises to ~8 ug/cm². That means leaving the drug on the scalp for an additional 12-14 hours before washing it off only offers an additional 3 ug/cm² of percutaneous absorption.

So, say that to minimize a partner’s exposure to finasteride means only keeping it on the scalp for 10 hours before washing it off. This begs the question: is the 5 ug/cm² of absorbed finasteride enough to therapeutically lower scalp levels of dihydrotestosterone (DHT) and regrow hair?

Topical Finasteride: How Long Does It Need To Stay In The Scalp To Be Effective?

There aren’t any clinical studies attempting to answer this question. However, a look at surrogate data can help ballpark an answer.

First, a percentage of topical finasteride will absorb into the dermis, and a smaller percentage of topical finasteride absorbed into the dermis will later absorb into the bloodstream. This means after applying topical finasteride; people can use time-dependent DHT reductions in the bloodstream to “ballpark” how much DHT is likely also getting reduced in the scalp. This is, again, because there is more topical finasteride that percutaneously absorbs than systemically absorbs.

So, for lower dosages, the effects we see in the system can be used as signals for what’s happening, at a minimum, in the scalp skin.

In that regard, see this figure from a 2014 study measuring the effects of one versus two applications of 1 mL of 0.25% topical finasteride on serum DHT levels. ^[3]https://pubmed.ncbi.nlm.nih.gov/25074865

Six hours after applying 1 mL or 2 mL applications of 0.25% topical finasteride (2.275-4.550 mg of finasteride), serum DHT reductions flatline. This means that for the 2 mL application group (the black circle with a dotted line), there was enough systemic absorption by the 6-hour mark to effectively lower serum DHT levels as much as they would normally lower with 1 mg of oral finasteride.

Keep in mind that finasteride has an upper limit for its effects on serum DHT reduction. After hitting ~70% reduction in serum DHT, more finasteride doesn’t reduce serum DHT. The same is true with scalp DHT reductions.

So, the above study shows that with topical finasteride applications of 2.275 mg or higher in a hydroxypropyl chitosan delivery vehicle, systemic reductions in DHT equal that of 1 mg of oral finasteride. And with topical finasteride, since serum DHT reductions are sort of like “canaries in the coal mine” for scalp DHT reduction, we can take an educated guess that 6-12 hours after applying topical finasteride. There’s likely enough percutaneous absorption to therapeutically lower scalp DHT levels for hair regrowth. 

This is corroborated by a 1997 study suggesting that 2 mL daily of 0.005% topical finasteride (0.0912 mg of finasteride exposure) improved hair parameters for men with AGA and without affecting serum DHT levels – even after 16 months of treatment. ^[4]https://www.tandfonline.com/doi/abs/10.3109/09546639709160517

Taken together, all of the above evidence signals that, depending on the exposure level, 6-12 hours of exposure to topical finasteride should be enough to have a therapeutic effect on scalp DHT reductions (and hair growth).

Do these time windows apply to all topical finasteride formulations?

No. Obviously, the contact time required for topical finasteride to be effective depends on a number of factors:

1. The finasteride dilution (i.e., 0.01% vs. 0.1% topical finasteride)
2. The volume of topical applied (i.e., 1 mL vs. 2 mL)
3. The topical’s carrier ingredients (i.e., hydroxypropyl chitosan vs. ethanol vs. propylene glycol vs. liposomes)
4. The frequency of application (i.e., once-daily, twice-daily, every-other-day, etc.)

Nonetheless, a 6-12 hour contact window should allow for therapeutic efficacy of many big-brand topical finasteride formulations available to consumers currently. However, if you’d like to get specific about adjustments on an individual basis, we offer that level of support inside our membership community.

Final Thoughts

For the most part, occasional incidental exposure to topical finasteride should not cause problems for household members. With that said, there are certain groups at an elevated risk – particularly pregnant women and children – and in these groups, cumulative risk over a lifetime of incidental topical finasteride exposure has yet to be studied.

If this is a concern for you, men and women can minimize the risk of incidental drug exposure from topical finasteride by doing any (or all) of the following:

1. Avoiding all physical contact with the scalp for at least 30 minutes after topical finasteride application (so that it fully dries)
2. Dedicating a pillowcase to the topical finasteride user, and washing that pillowcase weekly
3. Wearing a loosely-fitting shower cap to bed
4. Timing topical finasteride applications to 6-12 hour windows where the user is out-of-the-house and/or unlikely to come into contact with household members

Using the evidence and strategies above, our hope is that topical finasteride users can minimize or even eliminate the risk of incidental exposure, all while preserving their hair gains.

Fluridil: Scientific Deep-Dive

Fluridil, otherwise known as topilutamide (or by the brand name Eucapil) is a topical medication that has been tested as a treatment for both androgenetic hair loss and hirsutism (excess facial hair growth in women). In 2021, the patent for fluridil expired, however, there have been no generic fluridil treatments that have come to the market. Fluridil has been approved for cosmetic use in Europe but does not have FDA or EMA approval as a treatment for androgenetic alopecia. You can however buy this product on shopping websites, such as Amazon, for around $83 (at the time of writing). But is fluridil worth your money?

In this article, we will look at how Fluridil works, what the clinical evidence for it is, and whether it is safe to use.

Key Takeaways

• • Drug. Fluridil is an anti-androgenic drug that is currently on the market for the treatment of androgenetic alopecia and hirsutism. It is known to reduce the gene expression of androgens. Due to its similar structure to other anti-androgens, it’s thought to also exert its effect by binding to androgen receptors. As it readily breaks down in aqueous solutions, some researchers believe that it is safer to use than other anti-androgens, and can be applied locally without the risk of side effects on the rest of the body.
  • Clinical Data. There are only two studies that have been completed for fluridil: one on men and one on women. 
    • The first study was 9 months long and completed on 43 men with diagnosed androgenetic alopecia (AGA) aged between 20-56, in which 2mls of 2% fluridil was topically applied once nightly. Researchers found that in the first 3 months, there was a significant increase in the number of growing hairs, and a significant decrease in the number of non-growing hair, with no effects on testosterone levels or perceived sexual libido and function. Furthermore, fluridil, or its by-products, was not found to be present in the serum. Researchers also found, however, that the positive effects on the number of growing hairs/non-growing hairs did not last past the 3-month mark, and were instead maintained. A small safety study completed alongside this determined that either 2% or 4% fluridil was ok to use without adverse effects.
    • The second study was 9 months long and only completed on 11 women, 2 of which had to drop out of the study due to adverse effects from the isopropanol that the fluridil was diluted in. The participants applied 2mls of 2% fluridil, once nightly. The researchers did not find any significant change in growing or non-growing hairs, however, they did measure an increase in hair thickness. Due to the small sample size, the lack of a placebo, and the fact that every participant had taken another anti-androgenic medication within 3 months of the beginning of the study, it’s not possible to conclude whether fluridil has any effect or not for women with AGA.

• Safety. Unlike oral anti-androgenic drugs, fluridil should only work at the point of application as it should break down once it comes into contact with the blood. Additionally, across the limited parameters of both the studies mentioned above, no serious adverse effects were reported, however as both of the studies were 9 months long, with small sample sizes, we have no real information about what the long-term effects of fluridil usage may be.
• Best Practices. Based on the limited clinical data, if you decide to use fluridil, you could apply 2ml of a 2% fluridil solution in isopropanol once, at night before bed on a dry scalp (it will degrade if your hair or scalp is wet). You might be a candidate for fluridil if you are male with AGA (as the data isn’t sufficient for females with AGA), are comfortable with using a product that has very limited efficacy or safety data, have potentially seen results using other anti-androgens (such as finasteride), and don’t mind limiting hair washing to once or twice a week. If you’re interested in trying fluridil, although it’s not approved by the FDA, you can buy it on shopping sites like Amazon, and it’s possible that you may see limited results, at least over the first 3 months of usage.

Interested in Topical Finasteride?

Low-dose & full-strength finasteride available, if prescribed*

Take the next step in your hair regrowth journey. Get started today with a provider who can prescribe a topical solution tailored for you.

Click Here For 15% Off

*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

What is Fluridil?

As mentioned above, fluridil is a topical treatment that has been used in studies to determine its efficacy and safety in hair loss and excessive hair growth in women (hirsutism). 

Fluridil was synthesized alongside four other compounds in a study designed to discover a novel, topical anti-androgenic compound. ^[1]Seligson, A.L., Campion, B.K., Brown, J.W., Terry, R.C., Kucerova, R., Bienova, M., Hajduch, M., Sovak, M. (2003). Development of Fluridil, a Topical Suppressor of the Androgen Receptor in … Continue reading Androgens are linked to certain types of hair loss such as androgenetic alopecia.

The researchers were also searching for a compound that rapidly degraded (broken down) into non-harmful by-products in the blood so that it does not have effects at the systemic (whole-body) level (but rather limits its activity locally to the area of application). Out of the five total compounds synthesized, the researchers determined that fluridil best fit their criteria, which are described below:

1. Down-regulation of androgen receptors

The growth of prostate cancer is often androgen receptor-dependent.^[2]Fujita, K., Nonomura, N. (2019). Role of Androgen Receptor in Prostate Cancer: A Review. The World Journal of Men’s Health. 37(3), 288-295. Available at: https://doi.org/10.5534/wjmh.180040Therefore treating prostate cancer cells in a dish can be a useful way of seeing whether drugs have any anti-androgen receptor activity. In the human prostate cancer cell line LNCaP, fluridil reduced protein expression of androgen receptors by 40% at a concentration of 3μM, and by up to 95% at a 10μM concentration (Figure 1). Whilst this was not the most effective result, (BP-521 further reduced expression), it was the combination of this and results shown further down (Figure 2) that led the researchers to choose fluridil. Additionally, these compounds were compared to two other anti-androgen drugs (bicalutamide and hydroxyflutamide) and found that they did not decrease the expression of androgen receptors, indicating an additional mechanism of action of fluridil that other anti-androgen drugs may not have.

 

2. Degradation of the compound after incubation in human serum at 38°C

Fluridil was found to be the only compound that fully degraded in human serum by 48h of incubation (Figure 2). By contrast, BP-521, the compound that showed better down-regulation of androgen receptors barely showed any degradation, so did not match the criteria set by the researchers. 

Fluridil degrades into BP-34 which – as the researchers show in Figure 1 – doesn’t have a large effect on the expression of androgen receptors. It also degrades into a perfluorocarboxylic acid (PFCA) called trifluoroacetic acid (TFA) which mammals are thought to be insensitive to. ^[4]Solomon, K., Velders, G., Wilson, S., MAdronich, S., Longstreth, J., Aucamp, P., Bornman, J. (2016). Sources, Fates, Toxicity and Risks of Trifluoroacetic Acid and its Salts: Relevance to Substances … Continue reading

The researchers state that the by-products are non-toxic and that they should be processed rapidly by the kidneys because they are ionic. Ionic substances are attracted to water molecules and undergo dissociation, where they disperse throughout the water, and can therefore be excreted in the urine.^[5]Urine pH. (no date). University of Nottingham. Available at: https://www.nottingham.ac.uk/nmp/sonet/rlos/bioproc/kidneydrug/page_six.html (Accessed: 22 January 2022)

The researchers determined that based on their criteria, fluridil was the most promising in terms of its capacity to reduce androgen expression and due to its short half-life in aqueous solutions. This study however did not look at the efficacy of fluridil in the context of hair loss, and also did not provide data that established its safety in humans.

How does Fluridil work?

Androgenetic alopecia (AGA) is a form of hair loss with causes not yet fully understood, however, it is thought to be related to either excess androgens present, or an exaggerated response to androgens such as dihydrotestosterone (DHT). It affects both men and women and is characterized by progressive loss of hair over time in a particular pattern.^[7]Ho, C.H., Sood, T., Zito, PM. (2022). Androgenetic Alopecia. StatPearls [Internet]. Treasure Island (FL). Available at: https://www.ncbi.nlm.nih.gov/books/NBK430924/. (Accessed: 22 January 2023)

Fluridil belongs to a class of drugs known as non-steroidal anti-androgens (NSAAs). NSAAs are chemicals that stop androgens (like testosterone and DHT) from binding to their receptors. This means that androgens then can’t exert their effects, as they need to bind to these receptors to initiate the signaling events that can lead to hair follicle miniaturization, amongst other things. NSAAs may also be called androgen receptor antagonists, or androgen receptor blockers.  ^[8]Iverson, P., Melezinek, I., Schmidt, A. (2002). Nonsteroidal antiandrogens: a therapeutic option for patients with advanced prostate cancer who wish to retain sexual interest and function. BJUI … Continue reading ^[9]Ustuner, E.T. (2013). Cause of Androgenic Alopecia: Crux of the Matter. Plastic and Reconstructive Surgery. Global Open. 1(7), e64. Available at: https://doi.org/10.1097/GOX.0000000000000005

Receptors are specialized proteins in cells that allow specific chemicals to bind to them. In response to the correct chemical binding to the receptor, the receptor can exert downstream effects that have an impact on biology (a process known as signal transduction).^[10]Miller, E.J., Lappin, S.L. (2022). Physiology, Cellular Receptor. StatPearls [Internet]. Treasure Island (FL). Available at: https://www.ncbi.nlm.nih.gov/books/NBK554403/#_NBK554403_pubdet_ … Continue reading Other NSAAs include flutamide and bicalutamide. 

It’s important to note that there have been no studies to determine if this is really how fluridil works. Researchers have stated that this is because of fluridil’s instability in aqueous environments (meaning it is difficult to store, handle, and therefore study). Researchers hypothesize that because its structure is similar to other NSAAs, it has a similar mechanism of action, in addition to its ability to reduce the expression of androgen receptors. ^[11]Seligson, A.L., Campion, B.K., Brown, J.W., Terry, R.C., Kucerova, R., Bienova, M., Hajduch, M., Sovak, M. (2003). Development of Fluridil, a Topical Suppressor of the Androgen Receptor in … Continue reading

So, how fluridil actually works has not been fully determined, but is there any information on if and how fluridil affects hair follicles?

How can Fluridil have an impact on hair follicles?

Other than what has been hypothesized above (fluridil may be an androgen receptor inhibitor), it is not possible to know for sure exactly how fluridil might work on the hair follicle. As mentioned, there have been no studies in cells or isolated hair follicles in a dish  (which may be due to fluridil being unstable in aqueous environments). Cells and isolated hair follicles require physiological media solutions that contain all the nutrients needed to survive and grow, creating a barrier in experimentation with this drug/to experiment with this drug.

Furthermore, the only work completed on animals was in the initial paper in which the researchers completed skin irritant tests and absorption tests, where they found that fluridil was non-irritant at a concentration of 2% (the concentration at which they sell the product, although they don’t mention whether it’s weight/volume or volume/volume) and that there was no fluridil (or its by-products) detected in rabbit serum after a 1% solution was applied twice daily for 10 days. Samples were collected at 2, 5, 21, and 48 hours after treatment and then once every other day for the next 3 days. ^[12]Seligson, A.L., Campion, B.K., Brown, J.W., Terry, R.C., Kucerova, R., Bienova, M., Hajduch, M., Sovak, M. (2003). Development of Fluridil, a Topical Suppressor of the Androgen Receptor in … Continue reading

The most important thing however is whether, in humans, fluridil actually works and is safe to use. There have been two studies using fluridil in humans diagnosed with androgenetic alopecia. So let’s see if, regardless of knowing exactly how fluridil works, it is effective at treating hair loss.

Is Fluridil effective at treating hair loss?

There are currently only two studies that look at the efficacy and safety of fluridil in humans.

Study 1

The first study was a randomized, double-blind study to determine the efficacy and safety of a topical 2% fluridil solution on 43 men between 20-56 years of age with diagnosed AGA. ^[13]Sovak, M., Seligson, A.L., Kucerova, R., Bienova, M., Hajduch, M., Bucek, M. (2002).Fluridil, a Rationally Designed Topical Agent for Androgenetic Alopecia: First Clinical Experience. American … Continue reading Fluridil was dissolved in isopropanol to make the solution, because of its instability in water-based liquids. The participants were randomly assigned into two groups, 23 receiving the fluridil, and 20 receiving a placebo of just isopropanol. Participants were required to apply the fluridil or the placebo solution once nightly before bed, to avoid direct sun exposure and to only wash hair a maximum of twice a week using warm water.

After 3 months, the study then became open-label (all participants knew what they were receiving) and all participants began receiving the 2% fluridil solution with a further follow-up 6 months later (so the study was a total of 9 months long).

Data was collected through:

• Phototrichogram – an area of the hair is shaved (1.1cm2) and then photographed using a digital camera. Individual hairs/follicles are counted at baseline and at specific time points throughout.
• Calculating the ratio of growing (anagen) to non-growing (telogen) hairs.
• Global scalp imaging – photographs are taken of the entire scalp for subjective comparison.
• Blood collection – for measuring serum testosterone, measuring for the presence of serum fluridil and its by-products, and determining other relevant blood chemistry values.
• Self-perception questionnaire – for sexual function and libido

Results at 3 months

After 3 months, the number of growing to non-growing hairs was compared between the placebo and fluridil groups (Figure 3). The researchers found that the percentage of anagen hairs significantly increased from the baseline in the fluridil-treated group (75.68% at 0 months – 85.09% at 3 months) and the percentage of telogen hairs significantly decreased (25.41% at 0 months -14.61% at 3 months). The placebo group, however, also showed a significant decrease in the percentage of telogen hairs, however (29.51% at 0 months – 21.87 at 3 months) as well.

When comparing the fluridil-treated group to the placebo group after 3 months of treatment, the percentage of anagen hairs was higher in the fluridil (85.09% and 77.25% respectively). Furthermore, there were fewer telogen hairs in the fluridil-treated group than in the placebo group (14.61% and 21.87% respectively). 

At this point, the researchers decided that the effects of fluridil on hair growth were significant enough to change all participants to the treated group. It would however have been useful for the researchers to have stated what percentage of participants did see a positive effect.

Results at 9 months

To keep us all on track, by the end of the 9 months, the fluridil-treated group will have been using fluridil for 9 months, and the placebo group will have used the placebo for 3 months and then fluridil for 6 months. We’ll call the placebo group the ‘former placebo’ group now.

After counting growing and non-growing hairs, the researchers found that all groups now experienced significant increases in anagen hairs, and significant reductions in telogen hairs (Figure 4).

The researchers then compared the changes in growing and non-growing hairs after 3 months and 9 months for the fluridil-treated group and found that there were no significant differences, which indicates that there may be a limit to the effect that fluridil can have on hair growth, and that this limit might be achieved only within the first 3 months. Fluridil however did appear to maintain the number of growing/non-growing hairs after that. 

Let’s have a look at before-and-after images to see if this improvement shown in the data actually correlates to a visual improvement. Unfortunately, there is only one image shown (Figure 6), and we are left to wonder if this was the best case and if the reason that the others weren’t shown was that it was more difficult to see the improvements. Furthermore, there are no photos shown of anyone from the placebo group, so we cannot compare between groups. 

Other than measuring the number of growing/non-growing hairs, serum testosterone levels were also measured. Whilst variation between participants was observed, testosterone levels remained between the physiological range of 8-35 nm/L (Figure 7). Questionnaires also determined that participants did not experience any changes to libido or sexual performance either, however, it is not stated at what time points this data was collected. This is an indication that fluridil can only affect the hair follicle without leading to the systemic side effects that other anti-androgen drugs can cause. Additionally, the researchers did not detect fluridil or its by-product BP-34 in the serum of participants, further lending credence to this hypothesis.

A separate study within the same paper was completed with 20 male participants between the ages of 18-60. Patches containing 2,4, or 6% fluridil in either isopropanol or Vaseline Intensive Care Lotion were applied once a day for 21 days (excluding weekends) to determine if fluridil caused any irritancy to the skin. Isopropanol was also given alone as a control. 2% and 4% fluridil were found to be non-irritant and non-sensitizing. 6% fluridil however caused a slight degree of macular erythema (a rash with flat discolored areas of skin and small raised bumps).

So, to summarize, the data indicates that fluridil treatment leads to more growing hairs and fewer non-growing hairs. This effect however plateaus after 3 months, with no improvement or deterioration occurring after. Fluridil doesn’t appear to affect testosterone levels (which other anti-androgen medications can), and, holding up to the claim of hydrolyzation neither fluridil nor its by-product BP-34 were found to be present in the serum of participants throughout the study. There is only one comparison photo however, and while it does look like there is an improvement, it’s not possible to know if this was just the very best case or whether other participants also experienced a similar level of improvement. Of course, the long-term effects of fluridil (beyond 9-months) are unknown.

Study 2

The second study completed by the same research group was an open study. An open study is a study in which both participants and researchers are aware of what they are using. It sought to determine the efficacy and safety of a 2% fluridil solution in isopropanol on 11 female participants, aged 22-45, with diagnosed AGA. ^[19]Kucerova, R., Bienova, M., Novotny, R., Fiuraskova, M., Hajduch, M., Sovak, M. (2006). Current Therapies of Female Androgenetic Alopecia and Use of Fluridil, a Novel Topical Antiandrogen, Scripta … Continue reading

Participants were required to massage 2 ml of the fluridil solution into their scalps once a day, in the evening. 2 women discontinued the study due to itching and reddening that developed at the site after treatment. It was determined with an allergy study that this was due to the isopropanol causing irritation, rather than a reaction to the fluridil itself.

Participants were advised to only apply the solution to a dry scalp and to limit hair washes to a maximum of 2 times a week.

In this study, all 11 participants were treated with fluridil, so there was no placebo or a no-treatment group. A placebo group is useful in clinical trials as it provides a group to compare throughout the study. The participants are also aware that they are receiving the actual treatment without a placebo, which may influence the participant’s perception of the effect of the treatment. 

Several types of data were collected, including the following methods:

• Phototrichogram
• Global scalp imaging
• Hair Diameter measurement – an area of hair shaved and 3 weeks later ~50 new hairs collected and measured using a microscope.
• Changes in hair surface – five hairs from each patient were collected and prepared for scanning electron microscopy (SEM*).
• Evaluation by a physician (using a scoring system)

• Self-evaluation by participants (using a scoring system) to determine self-perception of hair growth and quality as well as effects on libido and sexual function.
• Blood tests – to measure serum testosterone, sex hormone binding globulin, other relevant blood chemistry, and serum fluridil or its by-products.

*(SEM is a special type of microscope that produces images of a sample by scanning the surface with electrons. These interact with the atoms that make up the sample, creating a much higher resolution image than might be obtained from a light-based camera). ^[20]Scanning Electron Microscopy. (no date). Nanoscience Instruments. Available at: https://www.nanoscience.com/techniques/scanning-electron-microscopy/ (Accessed: 22 January 2023)

Results

The authors of this study stated that they only included statistically significant data and what they considered to be “otherwise remarkable observations” in their results section.

The researchers found that fluridil treatment did not significantly increase the number of growing hairs or decrease the number of non-growing hairs over the whole study period (9 months), however, there was a significant improvement in hair diameter when it was measured at the 6 months and 9-month marks compared to the baseline. Whilst there are no images included in this paper, it is mentioned that the SEM images showed no changes in the overall morphology of the hair and that after evaluating global scalp images (photos taken from the top of the head) hair appeared to be thicker.

5 out of 11 participants reported that they perceived themselves to have reduced hair loss after 6 months of treatment. 1 out of 11 participants reported that they perceived their hair to have improved quality after 6 months, with another one reporting the same after 9 months. One person observed thickening of the hair (after 9 months), one reported new undergrowth (after 6 months) and one person reported accelerated hair growth (after 3 months). Undergrowth is the growth of short, fine hairs underneath longer hair.

So, not very convincing. We have measurements of hair diameter thickening but no data showing any increase in growing hairs or reduction in non-growing hairs. Moreover, the reported ‘positive’ data is almost entirely based on subjective patient self-reporting.

The safety data however does generally follow the same results as with the previous study on men, with no patients reporting adverse side effects. 

The blood chemistry data was within normal parameters throughout the study (measured at 3, 6, and 9 months) and there was no presence of fluridil or its by-products in the serum of any of the participants.

With regards to testosterone levels and sexual hormone binding globulin (SHBG), the researchers found no statistically significant differences between measurements taken at baseline and 9 months of treatment. There were however patients with higher than the physiological range of SHBG, which has been attributed to the fact that 8 out of 9 of the final patients were taking the combined oral contraceptive pill, which is known to increase SHBG. ^[22]Amiri, M., Tehrani, F.R., Nahidi, F., Kabir, A., Azizi, F. (2018). Comparing the Effects of Combined Oral Contraceptives Containing Progestins with Low Androgenic and Antiandrogenic Activities on the … Continue reading

So, why didn’t fluridil work in the same way for women as it did for men? Well, the researchers attribute this to the fact that the participants were taking cyproterone acetate (aka Diane 35) another anti-androgen, and (in some cases) contraceptive at least 3 months previous to the study. They determined that because they were taking Diane 35, it can be assumed that there was a sufficient anti-androgenic effect being exerted and so fluridil could not provide a further effect. 

But this is just one of several other problems with this study, such as:

• Small participant number
• No placebo
• Participants had been taking medication that may interfere with the efficacy of fluridil

Overall, we cannot conclude that fluridil has any real beneficial effect for women with AGA.

Is Fluridil safe?

Within the limited parameters of the published studies, fluridil doesn’t appear to have any treatment-related side effects. Furthermore, unlike taking oral anti-androgenic medications, fluridil should work only at the point of application and not have effects anywhere else in the body, due to its ability to degrade when it comes into contact with water.

However, fluridil has not been approved by the FDA or the European Medicines Agency as an anti-androgenic medication and is only approved for use in Europe as a cosmetic. The long-term effects of using fluridil are completely unknown.

Is Fluridil for me?

You may want to try fluridil if you:

• Are male with AGA.
• Want to either maintain the current status of hair loss or see short-term improvement and then a plateau.
• Are comfortable with using a product that has no FDA or EMA approval.
• Have no issues using a product that has very little recent (or otherwise) efficacy or safety data.
• Are ok with reducing hair washing to around once or twice a week.
• Have perhaps seen positive results with other anti-androgens (such as finasteride)

Whilst the previously mentioned points (easily degradable and topical application) may prove appealing, we cannot currently recommend using fluridil until more data becomes available. If you want to take the risk, however, it is possible that you may see some limited benefits.

 

Topical minoxidil is an FDA-approved treatment for male and female pattern hair loss, also known as androgenic alopecia (AGA).

Despite its popularity, not very many people continue using topical minoxidil for the long-run. In fact, one clinical study found that by the one-year mark, 95% of topical minoxidil users voluntarily quit applying the drug – with more than 2/3rds of them citing “low effect” as their rationale.^[1]https://pubmed.ncbi.nlm.nih.gov/17917938/

So, what sort of hair regrowth can we expect from minoxidil? Why do so many people quit using the topical? And what can we do to maximize minoxidil’s hair growth-promoting effects, and in doing so, set ourselves up for sustainable hair regrowth years into the future?

Interested in Topical Minoxidil?

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*Only available in the U.S. Prescriptions not guaranteed. Restrictions apply. Off-label products are not endorsed by the FDA.

What Is Minoxidil?

Topical minoxidil is the only medication approved by the FDA for the treatment of androgenic alopecia (AGA) in both males and females. Since its use as an anti-hypertensive drug in 1979, researchers have long-noted a nearly universal “adverse event” in oral minoxidil users: unexpected new hair growth along the limbs, chest, face, and scalp.^[2]https://pubmed.ncbi.nlm.nih.gov/7030707/

This led to to the reformulation of minoxidil as a topical, and subsequent clinical trials to test its efficacy on treating AGA. In 1988 and 1992, 5% and 2% minoxidil became commercial available as an over-the-counter hair growth treatment for men and women, respectively.

How Does Minoxidil Work?

Researchers aren’t totally sure how minoxidil regrows hair.

Having said that, they suspect that minoxidil may work through at least one (or all) of the following mechanisms:

• Opening potassium ion channels – which increases blood, oxygen, and nutrient transport to balding regions (i.e., increased microcirculation)
• Modulation of prostaglandin analogues (i.e., decreased inflammation)
• Anti-androgenic activity in hair follicle sites (i.e., decreased dihydrotestosterone (DHT) – the hormone causally linked to baldness).

How Much Regrowth Should We Expect From Minoxidil?

For more information on these topics, see this article: Minoxidil: How Long Do Results Last (Even After Quitting)?