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RECRUITINGPHASE1/PHASE2

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

NCT05891795•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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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 on the face
•consistent skin care regimen (topical and systemic medications) for at least 4 weeks prior to enrollment and continue it for the duration of the study (however, note exclusion below that topical steroids on face not allowed for 4 weeks prior to enrollment and during study)\*;
•age 16 years old or older
•potential participants who have ovaries and are or planning to be sexually active with partners that produce sperm will need to use a medically reliable form of birth control (including but not limited to condoms, intrauterine device, oral contraceptives) before enrollment and during the study
•* Note inhaled steroids are allowed as long as regimen is stable one month prior to enrollment and during the study

Exclusion Criteria

•changes in topical or systemic anti-acne medications or procedures within four weeks of study enrollment
•use of topical steroids on the face within 4 weeks prior to enrollment and during study
•pregnant or breast-feeding patients
•unable to provide informed consent, follow the protocol, attend study visits, or any other circumstance or condition which the investigator deems may obscure interpretation of results or affect safety of the potential participant.

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

July 22, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Acne Vulgaris

Interventions

Clascoterone 1% Top Cream

DRUG

Vehicle

DRUG

Contacts

Xiaochen Study Coordinator

CONTACT

408-816-0111 xczhong@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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