RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Topical Androgen Receptor Inhibitor for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy

Quick Facts

Study Start:2024-07-22

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05891795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

650-725-4178

farahat@stanford.edu

Principal Investigator

Anne Lynn S Chang, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Anne Lynn S Chang, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-07-22

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Acne Vulgaris