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

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clascoterone 1% Top Cream
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clascoterone<br> | Drug: Clascoterone 1% Top Cream<br>* Apply a thin layer to the affected area twice daily.<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Apply a thin layer to the affected area twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |