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

Primary Purpose

Acne Vulgaris

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clascoterone 1% Top Cream
Vehicle
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clascoterone

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 18, 2023
Last Updated
June 6, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05891795
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Masking will occur by the investigational pharmacy.
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clascoterone
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clascoterone 1% Top Cream
Intervention Description
Apply a thin layer to the affected area twice daily.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Apply a thin layer to the affected area twice daily.
Primary Outcome Measure Information:
Title
Change in number of papules/pustules
Description
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.
Time Frame
baseline, and month 3
Secondary Outcome Measure Information:
Title
Change in Acne-QoL scores
Description
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.
Time Frame
baseline, and month 3
Title
Change in serum testosterone
Description
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.
Time Frame
baseline, and month 3
Title
Change in sebum output
Description
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.
Time Frame
baseline, and month 3
Title
Change in microbiomic profile (measured by relative species abundance)
Description
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.
Time Frame
baseline, and month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Lynn S Chang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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