Clinical trial · Interventional
Topical Anti-Androgens in Pilonidal Sinus Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Cyst | — | UNRESOLVED | — |
| Pilonidal Disease | — | UNRESOLVED | — |
| Pilonidal Disease of Natal Cleft | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1% Clascoterone | Drug | — | UNRESOLVED |
| Vehicle Cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Clascoterone Treatment
- description
- 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.
- interventionNames
- Drug: 1% Clascoterone
- type
- PLACEBO_COMPARATOR
- label
- Placebo Treatment
- description
- 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.
- interventionNames
- Drug: Vehicle Cream
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDHebert 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
- BACKGROUNDKalabalik-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
- BACKGROUNDHargis 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