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

Launched by STANFORD UNIVERSITY · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called clascoterone for acne vulgaris, which is a common skin condition, in transgender male patients who are receiving testosterone as part of their masculinizing hormone therapy. Many existing acne treatments can interfere with hormone therapy, so there is a need for new options that work specifically for this group. Clascoterone is a cream that has been approved for acne treatment but hasn’t been tested in people using testosterone. The researchers want to see if it can help reduce acne that gets worse after starting hormone therapy.

To participate in the study, you need to be a transgender male or gender-diverse person who has been on a stable dose of testosterone for at least three months and has experienced acne since starting the treatment. You should be at least 16 years old and have at least 20 acne bumps on your face. Participants will need to continue their usual skin care routine and follow some guidelines regarding medications. If you’re interested, it’s important to know that the study is currently recruiting participants, and you will need to attend regular visits and follow the study rules throughout your participation.

Gender

ALL

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.