Testing Twice-Daily 1% Clascoterone Cream for Pilonidal Disease Treatment Over 12 Weeks

What this Trial Is About

Researchers are evaluating the topical drug clascoterone for pilonidal disease, a common, non-cancerous skin condition affecting the gluteal cleft. This randomized, double-blinded, placebo-controlled trial aims to determine whether clascoterone improves disease severity as assessed by physicians, reduces patient symptoms, and decreases inflammation seen under the microscope in tissue removed at surgery. Participants will be randomly assigned to apply either 1% clascoterone cream or a matching placebo cream twice daily to the affected area for 12 weeks. Assessments occur every 4 weeks, including medical photography of the diseased area, symptom surveys, and quality of life questionnaires. Those undergoing surgery within 4 weeks of treatment will have tissue samples analyzed for inflammation. Participants will attend visits at baseline and weeks 4, 8, and 12 for evaluations including physician assessments of disease severity through photos, the Dermatology Life Quality Index survey, and side effect monitoring. For those having surgery, wound healing and complications will be followed for 8 weeks post-operation. Tissue samples collected during surgery will be examined for immune cell presence and inflammation to compare effects between treatment groups.

Topical Anti-Androgens in Pilonidal Sinus Disease