Clascoterone Cream for Acne
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires you to keep your current skin care routine, including any topical or systemic medications, consistent for at least 4 weeks before joining and throughout the study. However, you cannot use topical steroids on your face during this time.
Is clascoterone cream safe for treating acne?
Clascoterone cream has been shown to be generally safe for treating acne in people aged 12 and older. Most side effects were mild, like skin redness and dryness, and serious issues were rare. There was no significant risk of high potassium levels in the blood, and no major safety concerns were noted in studies.12345
How is the drug Clascoterone cream different from other acne treatments?
Clascoterone cream is unique because it is the first topical antiandrogen treatment for acne, meaning it works by blocking male hormones (androgens) directly in the skin, unlike traditional oral treatments that affect the whole body. This makes it suitable for both males and females without the systemic side effects associated with oral antiandrogens.12678
What data supports the effectiveness of the drug Clascoterone cream for treating acne?
Research shows that Clascoterone cream, especially at a 1% concentration applied twice daily, significantly reduces acne lesions and is well tolerated by patients. It works by blocking androgens, which are hormones that can cause acne, and has been proven effective in both males and females over the age of 12.267910
Who Is on the Research Team?
Anne Lynn S Chang, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for transgender male patients aged 16 or older with acne that started or got worse after beginning masculinizing hormone therapy (MHT). They must have been on a stable MHT dose for at least 3 months and expect to continue the same dose. Participants need at least 20 papules or pustules and should maintain their current skin care routine throughout the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive clascoterone or placebo for acne treatment over a 3-month period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clascoterone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor