Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-24 @ 2:01 PM
NCT ID:
NCT05891795
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05891795
Study Brief:
Protocol Section:
NCT05891795