Topical Anti-Androgens in Pilonidal Sinus Disease

Description

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.

Conditions

Pilonidal Disease, Pilonidal Disease of Natal Cleft, Pilonidal Sinus, Pilonidal Cyst

Study Overview

Study Details

Study overview

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.

Topical Anti-Androgens in Pilonidal Sinus Disease

Topical Anti-Androgens in Pilonidal Sinus Disease

Condition
Pilonidal Disease
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Study Record Dates

2028-01-01