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

Stanford University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: Clascoterone 1% Top Cream

Drug: Vehicle

Study type

Interventional

Funder types

Other

Identifiers

NCT05891795

69870

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No 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.