Can I use clascoterone if I'm undergoing gender-affirming hormone therapy?

Clascoterone is a topical medication approved by the FDA in 2020 for treating acne in people over the age of 12. Its mechanism of action is based on locally blocking androgen receptors in the skin, without altering hormone levels in the blood. This has sparked growing interest in its potential use by transmasculine, non-binary, or gender-fluid individuals undergoing gender-affirming hormone therapy with testosterone who are experiencing side effects such as severe acne. But is it safe and effective to use clascoterone during hormone therapy? This question is not only valid—it’s urgent.

What clascoterone does (and what it doesn’t do)

Unlike medications such as spironolactone or systemic anti-androgens, clascoterone acts only on the skin. Its 1% cream formulation prevents the active ingredient from entering the bloodstream in significant amounts. Therefore, it does not reduce testosterone levels in the blood or interfere with the desired systemic effects such as voice deepening, increased muscle mass, or body hair growth. This makes it a promising option for treating acne without compromising the bodily changes many individuals seek when beginning testosterone therapy. However, because clascoterone is a relatively new drug, there are few studies specifically involving transgender populations.

Clascoterone during testosterone therapy: interference or relief?

Acne is a common side effect in people starting testosterone therapy. This happens because the sebaceous glands, responsible for producing oil in the skin, respond to increased androgen levels. Clascoterone, by blocking androgen receptors locally, reduces the activity of these glands in specific areas such as the face and back, where hormonal acne usually appears. But blocking these receptors in the skin does not mean stopping the effects of testosterone throughout the body.

This is crucial for many transmasculine or non-binary individuals who want to relieve acne without halting the changes they desire. To date, there is no evidence that the topical use of clascoterone alters the systemic effects of testosterone.

What we know (and what we don’t yet know)

Although clascoterone has been well studied in adolescents and adults with acne vulgaris, there are no published clinical trials specifically in trans people undergoing testosterone treatment. However, the accumulated knowledge about its pharmacokinetics allows for reasonably extrapolating certain conclusions. In a 2020 study conducted by Hebert et al., clascoterone showed minimal systemic absorption levels, even when applied to large areas of the skin. The study, sponsored by Cassiopea (the pharmaceutical developer), evaluated 18 adults with moderate to severe acne over 14 days of twice-daily application. The amount of drug absorbed was so low that it produced no measurable hormonal changes in the blood. This suggests its use remains local, without distant effects.

In the context of a gender-affirming transition, unwanted physical changes like severe acne can affect self-esteem and mental health. Qualitative studies have shown that trans people often face barriers in accessing appropriate dermatological treatments, increasing the risk of anxiety or depression associated with gender dysphoria. Therefore, having an effective and localized option like clascoterone can offer physical and emotional relief without jeopardizing the hormonal process.

User Experience

Clascoterone, a topical anti-androgen also known as Breezula (for hair loss) or Winlevi (for acne), is gaining attention among individuals undergoing gender-affirming hormone therapy (GAHT). Community discussions on Tressless reveal a growing curiosity about whether this medication can safely and effectively be used alongside testosterone or estrogen therapy—particularly for transmasculine and transfeminine individuals dealing with androgenic alopecia or hormonal acne. it acts directly on androgen receptors in the skin and scalp without significantly altering systemic hormone levels. This makes it a potentially safe option for those on GAHT who wish to avoid systemic anti-androgens that might conflict with their hormonal regimen or impact broader endocrine health.

A user participating in a Phase 3 trial of clascoterone for scalp use noted being part of a structured study, including marked scalp areas to monitor hair regrowth. Their participation suggests a level of confidence in the drug’s safety profile, even during hormonal transitions. Another user considering joining a trial after failing with topical finasteride and experiencing side effects from oral finasteride found clascoterone an attractive next step—presumably because it avoids systemic suppression of DHT, which is critical for some transgender individuals maintaining certain secondary sex characteristics.

However, while the safety of clascoterone in acne patients is well-documented, long-term community feedback specifically from transgender individuals remains sparse. One user expressed interest in how clascoterone might fit into a broader routine that includes minoxidil, especially since they were avoiding oral finasteride and RU58841 due to side effects or hormone-related concerns. This highlights that many in the transgender community are navigating treatment with great care to balance hair preservation with gender identity goals. Although community posts rarely mention detailed endocrinological concerns, there is a consistent focus on avoiding systemic anti-androgens that might interfere with HRT. Clascoterone, being topically confined with minimal systemic absorption, appears favorable in this context. One concern occasionally raised is about its strength compared to more potent anti-androgens, but the consensus leans toward its safety as a trade-off.

In summary, transgender users in the Tressless community seem to cautiously support the use of clascoterone alongside hormone therapy—valuing its localized effect and low risk of systemic interaction. However, they also recognize the need for more targeted research and community data. Based on the available evidence, clascoterone appears to be safe for people using testosterone as part of a gender-affirming transition. Its localized action and minimal systemic absorption make it unlikely to interfere with the desired effects of testosterone. However, the lack of specific studies in transgender populations limits the ability to make definitive claims. As always, the use of any medication should be evaluated in collaboration with a medical provider who understands both dermatological health and the particular needs of gender-affirming hormone therapy.

References

Del Rosso, J. Q. (2021). Clascoterone 1% Cream: A New Androgen Receptor Inhibitor for the Topical Treatment of Acne Vulgaris. Journal of Clinical and Aesthetic Dermatology, 14(1), 32–36. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7994728/

Hebert, A. A., Thiboutot, D., Stein Gold, L. F., Green, L. J., Cook-Bolden, F., Guenin, E. P., ... & Kerrouche, N. (2020). A Phase 2, Randomized, Double-blind, Vehicle-Controlled Trial to Assess the Safety and Efficacy of Clascoterone Cream, 1%, for the Treatment of Facial Acne Vulgaris. JAMA Dermatology, 156(6), 621–630. https://jamanetwork.com/journals/jamadermatology/fullarticle/2764792

U.S. Food & Drug Administration. (2020). Approval Letter for Winlevi (Clascoterone) Cream, 1%. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213176Orig1s000ltr.pdf

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