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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University

Criteria

Inclusion Criteria:

• transgender male or gender diverse patient on MHT

• on a stable dose of MHT for at least 3 months prior to the study

• anticipate being on the same dose of MHT for the duration of the study

• have steroid-related acne vulgaris as determined by the investigator with onset or worsening after initiation of MHT

• have at least 20 papules or pustules

• consistent skin care regimen (topical and systemic medications) for at least 1 month prior to enrollment and continue it for the duration of the study

• age 16 years old or older.

Exclusion Criteria:

• changes in topical or systemic anti-acne medications or procedures

• pregnant or breast-feeding patients

• unable to follow the protocol, attend visits, or provide consent.