drugset / Trial / NCT05891795

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

NCT05891795

Phase 1/2 Active not recruiting 18 enrolled Stanford University
RandomizedParallel-groupTriple-blindTreatment

Summary

Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.

Timeline

Start
2024-07-22
Primary completion
2026-01-31
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Clascoterone Small molecule 1 % Topical

Indications