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Topical Anti-Androgens in Pilonidal Sinus Disease

RECRUITINGPhase 2Sponsored by University of Pennsylvania
Actively Recruiting
PhasePhase 2
SponsorUniversity of Pennsylvania
Started2025-01-10
Est. completion2028-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

CancerPilonidal CystPilonidal DiseasePilonidal Disease of Natal CleftPilonidal Sinus

Locations1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19103
Lillias Maguire, MD215-662-2078lillias.maguire@pennmedicine.upenn.edu

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