Clinical trial NCT05891795: Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
Official title: Topical Androgen Receptor Inhibitor for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Change in number of papules/pustules
timeFrame: Week 0, and week 12
Secondary outcomes:
measure: Change in serum testosterone
timeFrame: Week 0, and week 12
measure: Change in sebum output
timeFrame: Week 0, and week 12
measure: Change in Acne-QoL and AI-ADL scores
timeFrame: Week 0, and week 12
measure: Change in microbiomic profile (measured by relative species abundance)
timeFrame: Week 0, and week 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Anne Lynn S Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: