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RECRUITING
NCT06286397
PHASE2

Topical Anti-Androgens in Pilonidal Sinus Disease

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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

DRUG

1% Clascoterone

Application of 1% clascoterone cream twice daily to affected area for 12 weeks.

DRUG

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