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Topical Anti-Androgens in Pilonidal Sinus Disease

NCT06286397 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

1% Clascoterone

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

DRUG

Vehicle Cream

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2028-01-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286397 on ClinicalTrials.gov