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Topical Anti-Androgens in Pilonidal Sinus Disease

RecruitingPhase 2

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: University of Pennsylvania · Participants: 75 · Started: Jan 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06286397

Locations in the U.S.

PennsylvaniaUniversity of Pennsylvania, Philadelphia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.