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

NCT05891795 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 69870
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in number of papules/pustules

  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.

  Week 0, and week 12

Secondary Outcomes (4)

• Change in serum testosterone

  Week 0, and week 12

• Change in sebum output

  Week 0, and week 12

• Change in Acne-QoL and AI-ADL scores

  Week 0, and week 12

• Change in microbiomic profile (measured by relative species abundance)

  Week 0, and week 12

Study Arms (2)

Clascoterone

EXPERIMENTAL

Drug: Clascoterone 1% Top Cream

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

Clascoterone 1% Top Cream DRUG

Apply a thin layer to the affected area twice daily.

Clascoterone

Vehicle DRUG

Apply a thin layer to the affected area twice daily.

Vehicle

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Anne Lynn S Chang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will occur by the investigational pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 7, 2023
• Study Start: July 22, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)