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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891795
• Other study ID #: 69870
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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
• consistent skin care regimen (topical and systemic medications) for at least 1 month prior to enrollment and continue it for the duration of the study
• age 16 years old or older.

Exclusion Criteria:

• changes in topical or systemic anti-acne medications or procedures
• pregnant or breast-feeding patients
• unable to follow the protocol, attend visits, or provide consent.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, and month 3
Secondary	Change in Acne-QoL scores	Patient reported outcomes will be measured using Acne-QoL (Acne Quality of Life Questionnaire) before starting the treatment (week 0) and following the 3-month course (week 12). The survey measures 4 different domains (self-perception, role-social, role-emotional, and acne symptoms) on a scale from 0-6, which 6 being the best.	baseline, and month 3
Secondary	Change in serum testosterone	Serum testosterone will be measured before starting the treatment (week 0) and following the 3-month course (week 12). We will use the change in serum testosterone to investigate if clascoterone, a local androgen receptor inhibitor, has systemic effects for transgender patients on MHT.	baseline, and month 3
Secondary	Change in sebum output	Sebum output will be measured using a Sebumeter SM815 probe (Courage & Khazaka, Köln or Cologne, Germany) before starting the treatment (week 0) and following the 3-month course (week 12). The specifications for the Sebumeter are as follows: Infrared 950 nanometers LED light, Type LED SFH 420 IR 950 nanometers, 1.8 voltz, 50 mAmps, CHIP-SMD. This specific apparatus has been used in several previous acne vulgaris studies. The patient will be asked to not use any topical preparations on their face 24 hours prior to these appointments. Measurements will be taken at the center of the forehead.	baseline, and month 3
Secondary	Change in microbiomic profile (measured by relative species abundance)	Skin microcomedone samples will be taken from the nose using Biore Deep Cleansing Pore Strips (Kao Brands Company, Cincinnati, OH) following the instructions of the manufacturer before starting the treatment (week 0) and following the 3 month course (week 12). Sample preparation and subsequent shotgun sequencing on microcomedone samples will be done commercially (MicrobiomeInsights). Shotgun metagenomic sequencing will be performed using Illumina 2x150 paired-end reads with a mean read depth of at least 6-7 million sequences per sample. High quality reads will undergo taxonomic profiling to obtain relative abundances. Change in microbiomic profile (measured by relative species abundance) will be used as a correlate for responders versus nonresponders.	baseline, and month 3