Using clascoterone cream to treat acne in transgender males on hormone therapy

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

This study is testing if clascoterone cream can help transgender males on hormone therapy clear up their acne without interfering with their treatment.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT05891795 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of clascoterone, a topical androgen receptor inhibitor, in treating acne vulgaris in transgender male patients undergoing masculinizing hormone therapy. Given the unique challenges of treating acne in this population, where traditional acne treatments may interfere with hormone therapy, this trial aims to fill a significant gap in acne management. Participants must have steroid-related acne that developed or worsened after starting hormone therapy and must adhere to a consistent skincare regimen. The study will compare the effects of clascoterone cream against a vehicle cream to assess its efficacy.

Who should consider this trial

Good fit: Ideal candidates are transgender male or gender diverse individuals aged 16 and older who are on stable masculinizing hormone therapy and have steroid-related acne.

Not a fit: Patients who do not have acne related to steroid use or those not on masculinizing hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted solution for managing acne in transgender males, improving their quality of life.

How similar studies have performed: While clascoterone has been FDA-approved for acne treatment, this specific application in transgender males on hormone therapy is novel and has not been previously studied.

Eligibility 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 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.

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Anne Lynn S Chang, MD — Stanford University
• Study coordinator: Xiaochen Study Coordinator

Conditions Acne Vulgaris