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RECRUITING
NCT05891795
PHASE1/PHASE2

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-07-22

Completion Date

2025-12

Last Updated

2025-05-18

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Stanford University

Stanford, California, United States