RECRUITING

Topical Anti-Androgens in Pilonidal Sinus Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Topical Anti-Androgens in Pilonidal Sinus Disease

Quick Facts

Study Start:2025-01-10
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06286397

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 and above
  2. * Diagnosis of Pilonidal Disease
  3. * Willingness to comply with study procedures and availability for duration of study
  4. * Ability to apply topical medications and willing to adhere to regimen
  1. * Current use of any topical medication to natal cleft
  2. * Presence of pilonidal-associated abscess
  3. * Pregnancy or lactation
  4. * Allergic reaction to components of 1% clascoterone cream
  5. * Febrile illness within 7 days
  6. * Treatment with another investigational drug within three months

Contacts and Locations

Study Contact

Lillias Maguire, MD
CONTACT
215-662-2078
lillias.maguire@pennmedicine.upenn.edu

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19103
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2025-01-10
Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

  • Pilonidal Cyst
  • Pilonidal Sinus
  • Clascoterone
  • Androgen

Additional Relevant MeSH Terms

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