Topical Anti-Androgens in Pilonidal Sinus Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
1% Clascoterone
DrugApplication of 1% clascoterone cream twice daily to affected area for 12 weeks.
Vehicle Cream
DrugApplication of a vehicle cream to the natal cleft twice daily for 12 weeks
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Clascoterone TreatmentExperimental treatment 1 intervention
Group B: Placebo TreatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 12 weeks2
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.
Time frame
From enrollment to the conclusion of treatment at 12 weeksSecondary outcomes
1
Subcutaneous Inflammation
The investigators anticipate that a large portion of subjects will ultimately undergo surgery. Those that undergo surgery within 4 weeks will be selected. At surgery, blinded investigators will measure the excisional defect. The investigators will then follow patients with chart review in the electronic medical record for 8 weeks postoperatively to assess for immediate wound complications. A full thickness representative sample of the excised pilonidal cyst will analyzed including: antibodies against CD3, CD4, CD8, CD68, and D79. Investigators will assess the specimens for hyperkeratosis, and follicular hyperplasia.
Time frame
From 12 weeks to 16 weeks after enrollment, only in patients who undergo surgerySponsors and contacts
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Source ClinicalTrials.gov