Is clascoterone suitable for both men and women?

Hair loss affects men and women differently. Not only do the patterns of hair thinning differ, but so do the hormonal causes, emotional impacts, and—most importantly—the way treatments interact with the body. Given this diversity, an urgent question arises: can a single active ingredient like clascoterone be both effective and safe for all sexes?

Types of alopecia: different causes, different challenges

Androgenetic alopecia is the most common form of hair loss in both men and women, but it presents very differently. In men, hair loss typically begins at the temples or crown, often progressing to baldness. In women, hair tends to thin more diffusely, especially along the center part, but rarely leads to complete baldness.

In addition to androgenetic alopecia, there are other forms of hair loss: alopecia areata (autoimmune-related), traction alopecia (from tight hairstyles or extensions), and telogen effluvium (temporary loss due to stress or hormonal changes). However, clascoterone is being developed specifically for androgenetic alopecia, a condition directly linked to a hormone called dihydrotestosterone (DHT). Is a derivative of testosterone. In genetically predisposed individuals, this hormone binds to androgen receptors in the scalp and causes hair follicles to shrink over time, producing increasingly finer hairs until growth stops. This process affects both men and women, although DHT levels and follicular sensitivity differ by sex. That’s where clascoterone comes in.

What is clascoterone, and why is it generating interest?

Clascoterone is a molecule that acts as an androgen receptor antagonist in the skin. Simply put, it blocks DHT from acting locally in the area where it’s applied, without interfering with the body’s overall hormone levels. This makes it very different from treatments like finasteride, which alters systemic hormone production. The best-known formulation of clascoterone is "Winlevi," a cream approved by the FDA in 2020 for treating acne in both male and female adolescents and adults. Its scalp version, "Breezula," is currently in development for androgenetic alopecia. The main appeal of clascoterone lies in being a topical treatment that avoids systemic hormonal side effects.

What does the science say about its use in men?

A phase II, randomized, double-blind, placebo-controlled study was conducted between 2016 and 2018 to evaluate the efficacy of 7.5% topical clascoterone in men with androgenetic alopecia. A total of 404 men aged 18 to 55 participated over a 12-month period. Results were assessed using standardized photographs and counts of terminal hairs (the thick, visible ones) in a defined area of the scalp. Men treated with clascoterone showed a statistically significant increase in terminal hair count compared to the placebo group, although the growth was described as "modest." The treatment was well tolerated and showed no significant systemic side effects.

This study demonstrated that clascoterone can slow follicle miniaturization and encourage some degree of regrowth. However, because the study included only men, its results cannot automatically be applied to women.

What about women?

While Winlevi is FDA-approved for acne in women, its use on the scalp is still under investigation. A clinical trial is currently underway to evaluate clascoterone specifically in women with androgenetic alopecia: study NCT05297902, launched in 2022. It includes women aged 18 to 55 with diagnosed female-pattern hair loss and is assessing the drug’s safety, efficacy, and tolerability over six months. Unlike treatments such as spironolactone—which is commonly used in women but carries hormonal risks—clascoterone has the potential to act directly on DHT-affected follicles without altering the body's overall hormonal balance. This is particularly important for women of reproductive age or those with hormonal sensitivities.

Although final results are not yet available, the existence of this trial—and its exclusive focus on women—marks an important step toward a safe topical alternative.

Is it truly safe for both sexes?

Clascoterone’s safety profile has been primarily evaluated in the context of acne treatment. In a pharmacokinetic study conducted as part of its FDA approval in 2020, clascoterone was applied to healthy skin and blood levels were measured. The results showed minimal systemic absorption, even with repeated applications, suggesting a very low risk of hormonal side effects. The fact that it has been FDA-approved for adolescents and adults of both sexes supports its safety profile. However, there is an important distinction between applying it to facial skin—as with Winlevi—and applying it to the scalp, where hair density and absorption characteristics differ. Therefore, alopecia-focused studies must confirm that this safety profile holds true with long-term scalp use.

So, is it suitable for both men and women?

Clascoterone presents a real and promising option for both men and women dealing with androgenetic alopecia. Its localized mechanism of action—without systemic hormonal impact—gives it a major advantage over treatments that do affect testosterone or estrogen levels. However, most clinical evidence so far has focused on men. While early signs in women are encouraging, the scientific community still awaits conclusive data before issuing formal recommendations. In the meantime, clascoterone use in women is considered off-label and should be evaluated individually by a dermatologist. With more ongoing research and promising preliminary findings, it’s likely that its use will expand across both sexes in the near future.

References

Cassiopea SpA. (2019). A Study to Evaluate the Efficacy and Safety of Clascoterone Solution for Treatment of Androgenetic Alopecia in Males (NCT03188505). U.S. National Library of Medicine. https://clinicaltrials.gov/study/NCT03188505

U.S. National Library of Medicine. (2022). A Study to Assess the Efficacy and Safety of Clascoterone Solution in Female Pattern Hair Loss (NCT05297902). https://clinicaltrials.gov/study/NCT05297902

U.S. Food and Drug Administration. (2020). FDA approves new acne drug for the first time in nearly 40 years. https://www.fda.gov/news-events/press-announcements/fda-approves-new-acne-drug-first-time-nearly-40-years