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Androgen Receptor Inhibitor

Clascoterone Cream for Acne

Phase 1 & 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and month 3

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I plan to keep my hormone therapy dose the same during the study.

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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.

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I am 16 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, and month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, and month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of papules/pustules

Secondary outcome measures

Change in Acne-QoL 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,332 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 Research Study Groups: Clascoterone, Vehicle

Acne 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots currently available for this clinical trial?

"In accordance with information posted on clinicaltrials.gov, this study is no longer recruiting participants after being initially listed on June 1st 2023 and last updated on May 26th 2023. However, 37 other medical trials are actively seeking enrolment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anne Chang 2024. "Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05891795.

All > Acne > Transgender