J Eur Acad Dermatol Venereol

2022 Feb;36(2):286-294.

doi: 10.1111/jdv.17738. Epub 2021 Oct 25.

Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial

B M Piraccini 1, U Blume-Peytavi 2, F Scarci 3, J M Jansat 3, M Falqués 3, R Otero 3, M L Tamarit 3, J Galván 4, V Tebbs 5, E Massana 3, Topical Finasteride Study Group

Abstract

Background: Oral finasteride is a well-established treatment for men with androgenetic alopecia (AGA), but long-term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles.

Objectives: To evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride.

Methods: This randomized, double-blind, double dummy, parallel-group, 24-week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone and dihydrotestosterone (DHT) concentrations were measured.

Results: Of 458 randomized patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs. 6.7 hairs; P < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at week 12 and investigator-assessed change from baseline in patient hair growth/loss at week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs. 55.6%), with topical vs. oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride.

Conclusion: Topical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and less impact on serum DHT concentrations.

Disclaimer

The information contained in this communication from the sender is confidential. It is intended solely for use by the recipient and others authorized to receive it. If you are not the recipient, you are hereby notified that any disclosure, copying, distribution or taking action in relation of the contents of this information is strictly prohibited and may be unlawful.

This email has been scanned for viruses and malware, and may have been automatically archived by Mimecast Ltd, an innovator in Software as a Service (SaaS) for business. Providing a safer and more useful place for your human generated data. Specializing in; Security, archiving and compliance. To find out more Click Here.

How effective is finasteride at stopping hair loss? I am 19 and have a receding hairline but thankful I caught it early. Started finasteride and just wondering if it can stop hair loss all together

Stopping hair loss with finasteride depends a great deal on your genetics. Finasteride can’t always stop your patterned hair loss if it is very aggressive.  There is a high probability that finasteride will either slow, stop or reverse the hair loss.  When it slows it down, it is hard to see because there is nothing to compare it to; however, if you are on finasteride for a long time and then stop it, “catch-up hair loss” will show that it was working. I wouldn’t advise someone to do this because there is no guarantee that the ‘catch-up hair loss’ can be fully reversed.

Great photo.  Good styling shows what happens when you probably have some reduced hair density and your comb your hair with good styling techniques. Styling is all important for those of you who are balding, especially in the early days of the balding process when the hair loss is just beginning.

I’m wondering if there are people here who had a transplant done at a late age, let’s say 40, and given their balding pattern and high quality of their donor hair they opted for not taking meds (fin, min, etc) and were mostly fine for 5-10 years, doing another procedure then.

If someone has bad sides from fin and their balding is not that aggressive (plus good donor area and cash) I think this would be a fine strategy. For example, for mature NW3+ people who just want to fill the crown.

When I perform a hair transplant on a 40 year old without recent hair loss, I don’t feel that finasteride is needed if the patient doesn’t want to take it. Shock loss from the hair transplantation in men without recent hair loss not common

This is a spectacular photo showing the early hair growth in a 22 y/o male taking finasteride on the hairline in just 6 weeks (early growth shown with arrow)

Hello Doc, I’m 26 and taking minoxidil twice a day, finasteride, and doing microneedling twice a day.  I take other medications as well. I will not quit medication because of the hair loss that I could get. Could you kindly tell from your point of view. What could be the reason of such an extremely fast diffuse thinning. I have developed a great deal of reversal from my Norwood Class 6 pattern of extreme thinning.  Many of the hairs got thicker and new hairs grew out.  Could the new regrowth cause the hair to thicken in next cycle? I know that is 6 months progress but maybe your experience give me more hope :) Number of new hairs is quite big but they do not cover scalp completely. Is the diameter of each hair a key to success ? What can i expect ? Should I change finasteride to dutasteride or fin will be sufficient?

I saw your photos on a previous post on reddit and you indeed did partly reverse extensive thinning of the Norwood Class 6 pattern of balding showing before you started treating it. You asked a complex question. Hair growth (Anagen) seems to be induced by wound healing (microneedling) in early balding or thinning but without constant stimulus, I believe that these hairs are eventually doomed. I believe that ingrained in each hair is a biologic clock that dictates the number of hair cycles a hair has when exposed to DHT. This can be altered with drugs and certainly its environment (hormones). Estrogens, for example, when present in significant concentrations without large amounts of testosterone (most females), seem to dictate a different number of hair cycles (women don’t develop Male Patterned Balding). This is just one example. As many of the readers know, I am working with a major university on a solution that might maintain anagen (hair growth) keeping it in its normal cycle, and possibly re-induce the anagen cycle again to the same hair when it goes through telogen. In a male, a normal hair cycle might be 2 – 3 years, so it will take time for us to know. Until we try it in humans, I can’t comment further.  We intend to use this discovery in a clinical trial sometime this year and from it, a new treatment for hair loss may arise.

You were very fortunate to have a good strong forelock prior to your surgery which will give you a strong frontal hairline. These forelocks are great and if they last until the age of 35, they usually last your lifetime. Some of these forelocks have a different genetic code than the hair around them.