Testing a topical treatment for pilonidal disease
Official title: Topical Anti-Androgens in Pilonidal Sinus Disease
Run by University of Pennsylvania · NCT06286397 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06286397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with pilonidal disease who can adhere to the treatment regimen.
✕Probably not a fit
Patients with asymptomatic disease, acute abscesses, or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of topical anti-androgens is a novel approach for pilonidal disease, similar studies have shown promise in treating other skin conditions.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sacral ESP Block to Help Pain After Pilonidal Sinus Surgery
This study tests whether an ultrasound-guided sacral erector spinae plane (ESP) block after pilonidal sinus surgery can reduce pain and opioid use.
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Wound cleaning during pilonidal surgery: saline vs. hypochlorous acid
This study tests whether irrigating the surgical wound with hypochlorous acid during pilonidal disease surgery helps wounds heal faster than saline in Stage 3 cases.
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Chlorhexidine (Irrisept) versus normal saline rinse for flap closure in pilonidal disease
This will see if rinsing the surgical wound with Irrisept (0.05% chlorhexidine) instead of normal saline reduces infections and other wound problems in adults having fasciocutaneous flap surgery for pilonidal disease.
-
Laser treatment with two-year follow-up for pilonidal cysts
This project will see if laser surgery prevents pilonidal sinus recurrence within two years in adults who need the procedure.
-
Impact of pilonidal cyst recurrence after surgery or laser on quality of life
This project will see how recurring pilonidal cysts after prior surgery or laser affect quality of life for patients who come back with a recurrence.
-
Improving wound healing for complex pilonidal sinus disease with a new care pathway
This study is testing a new care plan for people with complex pilonidal sinus disease to see if it helps them heal faster and get back to their normal activities better than the usual surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.