NCT05891795

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

Topical Androgen Receptor Inhibitor for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clascoterone 1% Top Cream	Apply a thin layer to the affected area twice daily.
DRUG	Vehicle	Apply a thin layer to the affected area twice daily.

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-06-07
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study