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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Masking will occur by the investigational pharmacy.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Clascoterone
  • Drug: Clascoterone 1% Top Cream
    Apply a thin layer to the affected area twice daily.
Placebo Comparator
Vehicle
  • Drug: Vehicle
    Apply a thin layer to the affected area twice daily.

Recruiting Locations

Stanford University
Stanford 5398563, California 5332921 94305
Contact:
Xiaochen Study Coordinator
408-816-0111
xczhong@stanford.edu

More Details

Status
Recruiting
Sponsor
Stanford University

Study Contact

Xiaochen Study Coordinator
408-816-0111
xczhong@stanford.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.