Topical Anti-Androgens in Pilonidal Sinus Disease

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06286397
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pilonidal Cyst
  • Pilonidal Disease
  • Pilonidal Disease of Natal Cleft
  • Pilonidal Sinus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1% Clascoterone — DRUG
    Application of 1% clascoterone cream twice daily to affected area for 12 weeks.
  • Vehicle Cream — DRUG
    Application of a vehicle cream to the natal cleft twice daily for 12 weeks

Study Details

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.

Key Dates

Start date
Jan 10, 2025
Status verified
Feb 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clascoterone Treatment
    Participants will apply 1% clasocterone cream to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.
  • Placebo Comparator: Placebo Treatment
    Participants will apply a vehicle cream matched in texture, appearance, and odor to clacoterone to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Primary Outcome Measure

Physician-Assessed Disease Severity Assessment [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19103
Lillias Maguire, MD
[email protected]
215-662-2078
Lillias Maguire, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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