NCT06286397 · University of Pennsylvania
Topical Anti-Androgens in Pilonidal Sinus Disease
What this study is about
The goal of this randomly assigned 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.
View original scientific 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.
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
Primary outcome measures
Physician-Assessed Disease Severity Assessment
Time frame: From enrollment to the end of treatment at 12 weeks
To objectively evaluate PSD, the investigators will obtain physical measurements of disease extent (left to right, cranial to caudal) and obtain disease photographs at baseline and weeks 4, 8, and 12. Photographs will be collected, deidentified, and provided to two colorectal surgeons for scoring. Surgeons will be asked to compare each timepoint to baseline and rate the PSD severity as significantly worsened, mildly worsened, unchanged, mildly improved, or significantly improved. Discrepant evaluations between surgeons will be referred to a third blinded surgeon. Data will be collated and analyzed in two fashions: as a 6-point ordinal outcome and collapsed into a dichotomous outcome with severely worsened to no change as a negative outcome and improvement as a positive outcome.
Dermatology Life Quality Index
Time frame: From enrollment to the conclusion of treatment at 12 weeks
Randomized subjects will be administered the Dermatology Life Quality Index (DLQI) at baseline and at 4, 8, and 12 weeks. The DLQI is a 10-question survey scored from 0-30 that has been applied widely across multiple dermatologic conditions and covers a range of potential quality of life impacts over a weekly basis. Specifically, the DLQI inquires about the impact of skin disease on symptoms (Example: "Over the past week, how itchy, painful, or stinging has your skin been?"), daily activities, leisure, work and school, and personal relationships, as well as a question of impact of treatment ("Over the last week, how much of a problem has the treatment of your skin been?"). Subjects respond Very much, A lot, A little, or Not at all for descending scores of 3 to zero. A score at or above 10 is considered a significant impact on quality of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations