Topical Anti-Androgens in Pilonidal Sinus Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Pilonidal Disease, Pilonidal Disease of Natal Cleft, Pilonidal Sinus, Pilonidal Cyst
In brief
The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are: * Does clascoterone improve the severity of pilonidal disease as scored by a physician? * Does clascoterone improve patient symptoms due to pilonidal disease? * Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey. Researchers will compare participants who received clascoterone treatment to those who received placebo.
Key facts
- Study ID
- NCT06286397
- Run by
- University of Pennsylvania
- People needed
- 75
- Starts
- 2025-01-10
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 and above
- Diagnosis of Pilonidal Disease
- Willingness to comply with study procedures and availability for duration of study
- Ability to apply topical medications and willing to adhere to regimen
You may not qualify if…
- Current use of any topical medication to natal cleft
- Presence of pilonidal-associated abscess
- Pregnancy or lactation
- Allergic reaction to components of 1% clascoterone cream
- Febrile illness within 7 days
- Treatment with another investigational drug within three months
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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