What this study is
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.
What's being tested
- 1% Clascoterone
Intervention · DRUG
Application of 1% clascoterone cream twice daily to affected area for 12 weeks.
- Vehicle Cream
Intervention · DRUG
Application of a vehicle cream to the natal cleft twice daily for 12 weeks
Study details
- Sponsor
- University of Pennsylvania
- Conditions
- Pilonidal Disease · Pilonidal Disease of Natal Cleft · Pilonidal Sinus · Pilonidal Cyst
- Enrolling
- 75 people
- Starts
- 2025-01-10
- Est. completion
- 2028-01-01
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Lillias Maguire, MD · Contact215-662-2078lillias.maguire@pennmedicine.upenn.edu
- Lillias Maguire, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID 855173
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.