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Androgen Receptor Inhibitor

Clascoterone Cream for Acne

Phase 1 & 2
Recruiting
Led By Anne Lynn S Chang, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Transgender male or gender diverse patient on MHT
Anticipate being on the same dose of MHT for the duration of the study
Must not have
Unable to follow the protocol, attend visits, or provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, and week 12

Summary

This trial explores using clascoterone to treat acne in transgender males receiving hormone therapy, as current treatments can interfere with their hormones.

Who is the study for?
This trial is for transgender male patients aged 16 or older with acne that started or got worse after beginning masculinizing hormone therapy (MHT). They must have been on a stable MHT dose for at least 3 months and expect to continue the same dose. Participants need at least 20 papules or pustules and should maintain their current skin care routine throughout the study.
What is being tested?
The study tests Clascoterone, an FDA-approved cream that blocks androgen receptors, which might help treat acne caused by testosterone in transgender males on hormone therapy. It's compared against a placebo cream (vehicle) to see if it's effective when other treatments are unsuitable due to interference with hormone therapy.
What are the potential side effects?
While specific side effects of Clascoterone in this context aren't detailed, common ones may include skin irritation, redness, itching, or peeling where the cream is applied. These are typical reactions for topical acne treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a transgender male or gender diverse and on hormone therapy.
Select...
I plan to keep my hormone therapy dose the same during the study.
Select...
I have 20 or more bumps or pus-filled pimples.
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I have been on a consistent hormone therapy dose for 3 months.
Select...
I am 16 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I can follow the study plan, attend visits, and give consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in number of papules/pustules
Secondary study objectives
Change in Acne-QoL and AI-ADL scores
Change in microbiomic profile (measured by relative species abundance)
Change in sebum output
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClascoteroneExperimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,922 Total Patients Enrolled
Anne Lynn S Chang, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Clascoterone (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05891795 — Phase 1 & 2
Acne Vulgaris Research Study Groups: Clascoterone, Vehicle
Acne Vulgaris Clinical Trial 2023: Clascoterone Highlights & Side Effects. Trial Name: NCT05891795 — Phase 1 & 2
Clascoterone (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891795 — Phase 1 & 2
~12 spots leftby Dec 2025
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