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Topical Anti-Androgens in Pilonidal Sinus Disease
Sponsor: University of Pennsylvania
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2025-01-10
Completion Date
2028-01-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
1% Clascoterone
Application of 1% clascoterone cream twice daily to affected area for 12 weeks.
Vehicle Cream
Application of a vehicle cream to the natal cleft twice daily for 12 weeks
Locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, United States