What is clascoterone and how does it work against hair loss?

Before understanding how clascoterone works, it is crucial to understand what it is fighting against. The most common cause of hair loss in both men and women is a condition known as androgenetic alopecia. This type of hair loss is driven by hormones—specifically a derivative of testosterone called dihydrotestosterone (DHT). DHT binds to receptors in hair follicles and gradually shrinks them, a process known as follicular miniaturization. Over time, the follicles become too small to support healthy hair growth, leading to thinner strands and eventually baldness. Androgenetic alopecia affects up to 50% of men and 25% of women by age 50. The key issue isn’t testosterone itself but how the body converts it into DHT, and more importantly, how that DHT interacts with the hair follicles. This is where clascoterone enters the picture.

There are also other common types of hair loss:

• Telogen effluvium, which often occurs after stress, illness, or hormonal shifts, like postpartum or due to thyroid problems.
• Alopecia areata, an autoimmune condition where the immune system attacks hair follicles, causing patchy baldness.
• Traction alopecia, caused by constant pulling or tension on the hair due to tight hairstyles.
• Scarring alopecias, where inflammation leads to permanent loss of follicles.

However, androgenetic alopecia remains the most prevalent form and the one most studied in relation to hormone-based treatments like clascoterone.

Clascoterone: A Topical Weapon in the Fight Against Hair Loss

Clascoterone is a topical anti-androgen, which means it works on the skin to block the activity of male hormones like DHT without altering hormone levels throughout the body. It is structurally similar to cortisol, a hormone your body naturally produces, but its function is different. Clascoterone specifically blocks DHT from binding to its receptors in the skin, including in the scalp, where it can harm hair follicles. Unlike oral treatments like finasteride—which reduce DHT levels throughout the body and may cause systemic side effects such as sexual dysfunction—clascoterone works locally, only where it is applied. This local action is what has raised excitement about its potential to treat hair loss with fewer side effects.

From Acne to Alopecia: The Road So Far

Clascoterone is not a completely new medication. In 2020, the U.S. Food and Drug Administration (FDA) approved it in a cream formulation (Winlevi 1%) for treating acne in patients aged 12 and older. It works by reducing sebum (oil) production and inflammation—both of which are influenced by DHT. This background made researchers consider whether clascoterone could also be used to block DHT’s effects in the scalp, potentially offering a treatment for androgenetic alopecia. This transition from a facial cream for acne to a scalp solution for hair loss is due to the shared hormonal mechanism: in both acne and androgenetic alopecia, DHT is the main culprit.

While Winlevi is sold as a 1% cream intended for facial skin, researchers are testing clascoterone in higher concentrations (up to 7.5%) and in liquid or foam solutions that can be applied to the scalp. These formats are different in texture and absorption behavior than a cream made for facial acne. This distinction is important because the skin on the scalp is different in thickness and sebum production from the face, and treatment must account for that.

User Experiences with Clascoterone for Hair Loss

Clascoterone, also known by its brand names Winlevi and Breezula, is generating increasing attention within the hair loss community as a topical antiandrogen that acts directly at the scalp. While originally FDA-approved for acne, its mechanism—blocking dihydrotestosterone (DHT) at the androgen receptor in skin cells—makes it a potential treatment for androgenetic alopecia (AGA). Many users on Tressless have begun exploring its potential, often sharing experiences ranging from cautious optimism to skepticism based on formulation strength and availability. One of the earliest discussions came from a user simply asking if anyone had heard about clascoterone for hair loss. The comments acknowledged its DHT-blocking mechanism and noted that it is being explored specifically for scalp application, similar to RU58841, but with the advantage of having already passed some regulatory hurdles for acne. Users mentioned pairing it with finasteride or minoxidil for compounded effects, especially in those who experienced side effects from systemic treatments like oral finasteride. Another active thread compared clascoterone with Fluridil, another topical antiandrogen. This user avoided oral finasteride due to side effects and was instead experimenting with clascoterone and minoxidil.

The concern was whether topical antiandrogens could maintain hair transplants, which are known to eventually miniaturize without DHT inhibition. The thread reflected cautious experimentation, with a focus on layering topical treatments without systemic exposure. One of the most notable contributions came from a user participating in a Phase 3 clinical trial of clascoterone for hair loss. They shared that their scalp was being marked with a tattoo and a portion shaved to monitor effects, providing rare insight into the structure of clinical evaluation. Though results were not yet available, the high engagement from others in the thread indicated strong interest in data-backed alternatives to existing treatments.

News of its approval in Canada also stirred conversation. Some users expressed skepticism over the effectiveness of the current 1% acne formulation when used on the scalp, citing concerns over concentration and absorption. Others saw this as a stepping stone toward broader acceptance and future access to the higher-dose Breezula formulation under development for androgenetic alopecia. In older posts, dating back to 2019 and earlier, users already showed hope in Breezula’s development. Positive interim results from Phase 2 trials were met with excitement, especially since the formulation didn’t appear to lower cortisol levels, avoiding one of the systemic risks of traditional antiandrogens.

Finally, some users explored off-label use of Winlevi (clascoterone 1%) for conditions like seborrheic dermatitis and hormonal acne, noting potential crossover benefits for those with mixed scalp conditions. These reports help validate clascoterone’s sebum-regulating and anti-inflammatory properties beyond just hair follicle miniaturization. In summary, the Tressless community views clascoterone as a promising but still developing option in the fight against AGA. Its appeal lies in its topical nature, minimal systemic absorption, and mechanism directly targeting DHT action at the follicular level. However, limitations related to current concentration, access, and long-term data remain key barriers to widespread use. Still, community involvement in trials and experimental protocols suggests growing faith in its future potential.

How Does Clascoterone Actually Work on the Scalp?

When applied to the scalp, clascoterone binds to androgen receptors in the skin and hair follicles. These are the same receptors DHT normally binds to in order to exert its damaging effects. By occupying these receptors, clascoterone prevents DHT from binding and triggering the miniaturization of hair follicles. Because clascoterone is applied directly to the scalp, its action is mostly local. This reduces the risk of side effects commonly associated with systemic anti-androgens. Studies so far suggest that clascoterone does not significantly alter hormone levels in the bloodstream, making it a potentially safer alternative for people sensitive to hormonal treatments.

Yes, the mechanism involves applying the product directly to the scalp, just like with minoxidil. In the clinical studies evaluating its effectiveness against hair loss, clascoterone was formulated as a topical solution (not a cream) and applied twice daily on the balding areas of the scalp. It's important to note that using the 1% cream made for acne on the scalp is not recommended without medical guidance. The delivery system, concentration, and skin absorption are all optimized differently for facial use compared to scalp treatment.

What Do the Studies Say?

A preclinical study conducted in 2014 explored the effects of clascoterone on human scalp dermal papilla cells obtained from individuals with androgenetic alopecia. The research, which took place in vitro (outside a living organism), measured the expression of genes influenced by androgens after the application of clascoterone. **The results showed a significant reduction in androgen-induced gene expression, indicating strong anti-androgenic activity at the follicular level. However, a major limitation of the study is that it was performed in a controlled lab setting on isolated cells, so it does not necessarily reflect how clascoterone behaves in a living human body. Additionally, the study did not evaluate actual hair regrowth. **

A Phase II clinical trial completed in 2021 involved 404 male participants between the ages of 18 and 55 who were experiencing androgenetic alopecia. This randomized, double-blind, placebo-controlled study tested a 7.5% clascoterone solution applied topically over 12 months. The primary measure of effectiveness was the change in hair count in a target area of the scalp after 6 and 12 months. The results showed a statistically significant improvement in hair density in the clascoterone group compared to the placebo group. Side effects were mild and mainly limited to localized irritation or redness. Importantly, no significant systemic hormonal side effects were reported. However, as a Phase II trial, further studies are necessary to confirm these findings and to explore effectiveness in women and broader populations.

In 2020, clascoterone (as Winlevi 1%) was approved by the FDA for the treatment of acne following two large Phase III clinical trials involving 1,440 patients aged 12 and up. These trials lasted 12 weeks and focused on reducing acne lesions and overall skin inflammation. The evaluation included the Investigator’s Global Assessment (IGA) score and total lesion counts. **Results demonstrated a statistically significant improvement over placebo, and the treatment exhibited minimal systemic absorption—a key factor that supports its potential for use in other hormone-sensitive conditions like hair loss. While the focus was acne, this approval laid the groundwork for subsequent research into its broader dermatological applications. **

What Sets Clascoterone Apart From Other Treatments?

Current treatments for androgenetic alopecia mainly include minoxidil (topical) and finasteride (oral). Minoxidil is a vasodilator, meaning it widens blood vessels, improving blood flow to the scalp and encouraging hair growth. However, it does not block the hormonal causes of hair loss. Finasteride blocks the enzyme 5-alpha-reductase, which converts testosterone into DHT. While effective, finasteride affects DHT levels throughout the body, which can lead to side effects such as reduced libido, erectile dysfunction, and mood changes in some users. Clascoterone, in contrast, blocks DHT only where it is applied, potentially offering the hormonal benefits of finasteride with the local safety profile of minoxidil.

When Will It Be Available?

As of mid-2025, clascoterone is not yet FDA-approved for the treatment of hair loss, though several clinical trials are ongoing. The early data is encouraging, and dermatologists are watching closely. Given the promising safety profile and mechanism of action, approval could offer a new option for individuals—especially women—who are wary of systemic hormonal treatments. Based on current research, clascoterone shows great promise as a topical treatment for androgenetic alopecia. It directly answers the core issue: how to stop DHT from damaging hair follicles without affecting hormones throughout the body. The evidence from early human studies, alongside its success in treating acne, supports its anti-androgenic potential.

However, more long-term and diverse clinical trials are needed before we can say it is a definitive solution. What we can say, though, is that clascoterone could reshape the future of hair loss treatment.

References

Bodor, N., & Buchwald, P. (2014). Clascoterone inhibits androgen-induced gene expression in balding scalp dermal papilla cells. Journal of Investigative Dermatology, Abstract retrieved from https://pubmed.ncbi.nlm.nih.gov/24889137/

Cosmo Pharmaceuticals. (2021). A Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Clascoterone Solution for Androgenetic Alopecia in Males. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/study/NCT03867285

U.S. Food and Drug Administration. (2020). Winlevi (clascoterone) cream, 1% prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213472s000lbl.pdf Reddit user. (2024, December 17). Anybody heard about clascoterone against hair loss? Retrieved from https://reddit.com/r/tressless/comments/1hg31zm/anybody_heard_about_clascoterone_against_hair_loss/

Reddit user. (2024, September 22). Clascoterone vs fluridil, and using them with minoxidil. Retrieved from https://reddit.com/r/tressless/comments/1fn4tj7/clascoterone_vs_fluridil_and_using_them_with/

Reddit user. (2024, April 26). Clascoterone study going on right now. Retrieved from https://reddit.com/r/tressless/comments/1cd9cxc/clascoterone_study_going_on_right_now/

Reddit user. (2023, July 12). Clascoterone (Winlevi) now approved in Canada. Retrieved from https://reddit.com/r/tressless/comments/14xui92/clascoterone_winlevi_now_approved_in_canada/

Reddit user. (2019, April 16). Cassiopea Announces Very Positive Phase II Twelve Months Results for Breezula® (Clascoterone) in Treating Androgenetic Alopecia. Retrieved from https://reddit.com/r/tressless/comments/bdr2f6/cassiopea_announces_very_positive_phase_ii_twelve/

Reddit user. (2024, February 4). Using WinLevi (Clascoterone) for Seborrheic Dermatitis and Acne. Retrieved from https://reddit.com/r/tressless/comments/1aixe8g/using_winlevi_clascoterone_for_seborrheic/