NCT06286397 Topical Anti-Androgens in Pilonidal Sinus Disease
| NCT ID | NCT06286397 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Pennsylvania |
| Condition | Pilonidal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2025-01-10 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06286397 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pilonidal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06286397 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06286397 currently recruiting?
Yes, NCT06286397 is actively recruiting participants. Contact the research team at lillias.maguire@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06286397 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06286397 clinical trial?
NCT06286397 is sponsored by University of Pennsylvania. The trial plans to enroll 75 participants.