Recruiting
Phase 2

Clascoterone

Sponsor:

University of Pennsylvania

Code:

NCT06286397

Conditions

Pilonidal Disease

Pilonidal Disease of Natal Cleft

Pilonidal Sinus

Pilonidal Cyst

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

1% Clascoterone

Vehicle Cream

Study Details

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

Study ID

NCT06286397

Start date

Jan 10, 2025

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clascoterone Treatment

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.

placebo comparator: Placebo Treatment

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.

Interventions

1% Clascoterone

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

Vehicle Cream

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

Primary outcome measure

  • Physician-Assessed Disease Severity Assessment [ Time Frame: From enrollment to the end of treatment at 12 weeks ]
  • Dermatology Life Quality Index [ Time Frame: From enrollment to the conclusion of treatment at 12 weeks ]

Central Contacts and Locations

Central contacts

Lillias Maguire, MD

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Contacts

Lillias Maguire, MD

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

Principal Investigator:

Lillias Maguire, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Pilonidal Cyst
  • Pilonidal Sinus
  • Clascoterone
  • Androgen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-27.