RecruitingPhase 2NCT06286397

Topical Anti-Androgens in Pilonidal Sinus Disease


Sponsor

University of Pennsylvania

Enrollment

75 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

DRUG1% Clascoterone

Application of 1% clascoterone cream twice daily to affected area for 12 weeks.

DRUGVehicle Cream

Application of a vehicle cream to the natal cleft twice daily for 12 weeks


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06286397


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