Topical Anti-Androgens in Pilonidal Sinus Disease

NCT06286397 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 855173
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pilonidal Cyst; Pilonidal Sinus; Clascoterone; Androgen

Outcome Measures

Primary Outcomes (2)

• Physician-Assessed Disease Severity Assessment

  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.

  From enrollment to the end of treatment at 12 weeks

• Dermatology Life Quality Index

  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.

  From enrollment to the conclusion of treatment at 12 weeks

Secondary Outcomes (1)

• Subcutaneous Inflammation

  From 12 weeks to 16 weeks after enrollment, only in patients who undergo surgery

Study Arms (2)

Clascoterone Treatment

EXPERIMENTAL

Participants will apply 1% clasocterone cream to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Drug: 1% Clascoterone

Placebo Treatment

PLACEBO COMPARATOR

Participants will apply a vehicle cream matched in texture, appearance, and odor to clacoterone to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Drug: Vehicle Cream

Interventions

1% Clascoterone DRUG

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

Clascoterone Treatment

Vehicle Cream DRUG

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

Placebo Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Related Publications (3)

• Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

  PMID: 32320027 BACKGROUND

• Kalabalik-Hoganson J, Frey KM, Ozdener-Poyraz AE, Slugocki M. Clascoterone: A Novel Topical Androgen Receptor Inhibitor for the Treatment of Acne. Ann Pharmacother. 2021 Oct;55(10):1290-1296. doi: 10.1177/1060028021992053. Epub 2021 Feb 3.

  PMID: 33533262 BACKGROUND

• Hargis A, Yaghi M, Maskan Bermudez N, Lev-Tov H. Clascoterone in the treatment of mild hidradenitis suppurativa. J Am Acad Dermatol. 2024 Jan;90(1):142-144. doi: 10.1016/j.jaad.2023.08.064. Epub 2023 Sep 2. No abstract available.

  PMID: 37660976 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

Lillias Maguire, MD

CONTACT

215-662-2078; lillias.maguire@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blinded, Placebo-Controlled Trial

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)