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Clascoterone for Acne in Transgender Men on Hormone Therapy

This study is testing Clascoterone 1% Top Cream to treat acne (acne vulgaris) in transgender men and gender-diverse individuals who are receiving masculinizing hormone therapy (MHT). Many current acne treatments can interfere with hormone therapy, so this study aims to find a safe and effective option. You might be able to join if you are at least 16 years old, are on a stable dose of MHT, and have at least 20 acne bumps (papules or pustules) on your face. Participants will apply either Clascoterone or a Vehicle (a cream without the active drug) twice daily. The main goal is to see how much the number of acne bumps changes over 12 weeks. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 18 participants. It compares Clascoterone 1% Top Cream to a Vehicle (a cream without the active drug).
What's involved
Participants will apply a thin layer of cream to the affected area twice daily for 12 weeks. The number of acne bumps will be measured at the start and at week 12.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks to measure changes in their acne.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05891795

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

Active, Not Recruiting
PHASE1Ages 16+InterventionalTreatment
Stanford University
~18 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Clascoterone 1% Top CreamVehicle

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in number of papules/pustules
Measured over Week 0, and week 12

Conditions

Acne Vulgaris

Explore related trials

Acne

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Anne Lynn S Chang, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in number of papules/pustulesWeek 0, and week 12

    Total count of papules (including pustules) will be measured on the entire face at screening and monthly during the three month treatment period. Change in total papules count will be used to compare the efficacy of clascoterone 1% cream versus vehicle at time point week 12 versus week 0.