Transgender Male Acne Research Study
Researchers at Stanford University are conducting a study on a new acne treatment specifically for transgender males and gender-diverse individuals on testosterone.
Fast Facts
Transgender Male or Gender Diverse on Testosterone
Have Acne That Started or Worsened With Beginning Testosterone
Compensation Provided
Conducted in Redwood City, CA
Study Background
Acne is a common side effect of testosterone usage for transgender males and gender-diverse individuals. While androgens play a key role in the development of acne vulgaris, many of the standard acne treatments used for cisgender females, such as oral contraceptives and anti-androgen medications, are not suitable for individuals on testosterone as they can interfere with hormone therapy. This leaves a significant gap in effective, mechanism-based treatment options for transgender patients experiencing testosterone-induced acne.
Clascoterone is a topical androgen receptor inhibitor cream that has been FDA-approved for acne, but clinical trials have historically excluded participants on exogenous hormones. This study aims to explore whether clascoterone can effectively treat acne in transgender males and gender-diverse individuals on testosterone without interfering with their hormone therapy. By addressing this unmet medical need, researchers hope to provide a new, safe, and effective acne treatment option for individuals using testosterone.
Study Background
This study explores the effectiveness of clascoterone, an FDA-approved topical androgen receptor inhibitor, in treating testosterone-induced acne in transgender males and gender-diverse individuals on testosterone.
Acne is a common side effect of testosterone usage for transgender males and gender-diverse individuals. While androgens play a key role in the development of acne vulgaris, many of the standard acne treatments used for cisgender females, such as oral contraceptives and anti-androgen medications, are not suitable for individuals on testosterone as they can interfere with hormone therapy. This leaves a significant gap in effective, mechanism-based treatment options for transgender patients experiencing testosterone-induced acne.
Clascoterone is a topical androgen receptor inhibitor cream that has been FDA-approved for acne, but clinical trials have historically excluded participants on exogenous hormones. This study aims to explore whether clascoterone can effectively treat acne in transgender males and gender-diverse individuals on testosterone without interfering with their hormone therapy. By addressing this unmet medical need, researchers hope to provide a new, safe, and effective acne treatment option for individuals using testosterone.
Additional Information
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Transgender male or gender diverse on testosterone
- Have acne that started or worsened with beginning testosterone
- On a stable dose of testosterone for at least 3 months prior to the study and planning on maintaining current dose
- Ages 16+
- Consistent skin care regimen during the study (topical and systemic medications) for at least 4 weeks prior to enrollment and during study
- Have at least 20 papules or pustules
- If sexually active or plan to be sexually active with partner(s) that produce sperm and participant has ovaries, willing to use a medically reliable form of birth control (including but not limited to condoms, intrauterine device, oral contraceptives) prior to starting the study and during the study
If you choose to participate in this study, you will use either a topical cream called clascoterone or a placebo cream twice a day for 12 weeks. During the study, researchers will:
- Perform blood pressure checks, blood draws, and a pregnancy test (if applicable).
- Measure your skin’s oil levels using a special paper.
- Collect microbiome swabs to analyze microbes on your skin.
- Count the number of acne spots on your face.
- Ask you to complete surveys about your experience.
This study includes 4 in-person visits at Stanford’s Redwood City clinic (Screening/Week 0, Weeks 4, 8, and 12) and a follow-up phone call 4 weeks after the study ends.
You will receive a $100 e-gift card after each in-person study visit, for a total of $400 if you complete all visits.
Transportation: If you take Caltrain, a free shuttle is available between the Redwood City Caltrain station and the Dermatology clinic.
There is no cost for you to participate in our research study.