Topical Anti-Androgens in Pilonidal Sinus Disease
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.
Description
This is a randomized, double-blinded placebo-controlled trial. Recruitment The investigators will recruit patients from the University of Pennsylvania colorectal surgery clinics which consist of six high-volume surgeons and five advance practice providers across three hospitals serving a major metropolitan area. Patients considered for elective surgery will be recruited for the study and undergo a thorough informed consent process. Patients with asymptomatic disease and those with acute abscesses will be excluded as will patients who are pregnant or concurrently on a systemic anti-androgen (i.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Interventions
- Drug1% Clascoterone
Application of 1% clascoterone cream twice daily to affected area for 12 weeks.
- DrugVehicle Cream
Application of a vehicle cream to the natal cleft twice daily for 12 weeks
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania