Testing a topical treatment for pilonidal disease
Topical Anti-Androgens in Pilonidal Sinus Disease
This study is testing a new cream to see if it can help people with pilonidal disease feel better and reduce their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06286397 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded, placebo-controlled trial aims to evaluate the efficacy of clascoterone, a topical anti-androgen, in treating pilonidal disease. Participants will apply either clascoterone or a placebo cream to the affected area twice daily for 12 weeks. The study will assess changes in disease severity, patient symptoms, and inflammation through physician evaluations and patient surveys. Recruitment will occur at the University of Pennsylvania's colorectal surgery clinics, involving a thorough informed consent process and regular assessments throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with pilonidal disease who can adhere to the treatment regimen.
Not a fit: Patients with asymptomatic disease, acute abscesses, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of pilonidal disease and enhance patient quality of life.
How similar studies have performed: While the use of topical anti-androgens is a novel approach for pilonidal disease, similar studies have shown promise in treating other skin conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Lillias Maguire, MD
- Email: lillias.maguire@pennmedicine.upenn.edu
- Phone: 215-662-2078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.