Topical Anti-Androgens in Pilonidal Sinus Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 1% Clascoterone
- Vehicle Cream
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov