Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286397
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-02-22
Brief Title:
Topical Anti-Androgens in Pilonidal Sinus Disease
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Topical Anti-Androgens in Pilonidal Sinus Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
This is a randomized double-blinded placebo-controlled trial Recruitment The investigators will recruit patients from the University of Pennsylvania colorectal surgery clinics which consist of six high-volume surgeons and five advance practice providers across three hospitals serving a major metropolitan area Patients considered for elective surgery will be recruited for the study and undergo a thorough informed consent process Patients with asymptomatic disease and those with acute abscesses will be excluded as will patients who are pregnant or concurrently on a systemic anti-androgen ie spironolactone At the intake visit patients will undergo a 11 randomization performed by the University of Pennsylvanias Investigational Drug Service IDS Recruited subjects will receive clascoterone or a vehicle cream matched for consistency color and container so that both subject and investigator are blinded to the assignment At the intake visit subjects will be advised to apply cream to cover the affected area twice daily for 12 weeks At the intake visit baseline disease assessment will be obtained including demographics height and weight medication usage and personal history of PSD such as disease onset and prior procedures Baseline disease measurements and medical photography will be obtained Photographs will be taken with a dedicated camera patients given a codified study ID and data entered into a deidentified HIPAA- compliant database
I Objective assessment of Disease Severity Medical photography and analysis 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
II Assessment of Dermatology Quality of Life 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 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 Responses to the individual questions will be summed and responses compared between groups after unblinding at data analysis
III The investigators anticipate that a large portion of subjects in both groups will ultimately undergo surgery Those that undergo surgery within 4 weeks will be selected for these analyses on the hypothesis that the effect of clascoterone may subside at a longer interval At surgery blinded investigators will measure the left-right cranial-caudal and superficial-deep measurements of the excisional defect with a sterile ruler The investigators will then follow patients with chart review in the electronic medical record for 8 weeks postoperatively to assess for immediate wound complications such as cellulitis wound separation abscess and early recurrence
III Assessment of Cutaneous Inflammation A full thickness representative sample of the excised pilonidal cyst and adjacent normal tissue will be obtained at operation fixed in formalin and delivered to the skin phenomics core of the University of Pennsylvania Skin Biology Disease Research Core SBDRC Following de-paraffination rehydration antigen retrieval and blocking as necessary SBDRC-validated antibodies will be applied to characterize the inflammatory infiltrate specifically anti- CD3 T- cells and Natural Killer Cells anti-CD4 helper T-cells anti-CD8 cytotoxic T-cells anti-CD68 macrophages anti-CD79 B cells Investigators blinded to treatment groups will assess the specimens for epidermal dermal and subcuticular inflammatory infiltrates hyperkeratosis and follicular hyperplasia Antibody-positive cells will be counted in six randomly selected fields under a light microscope at 400x magnification Cell counts will be tallied and means and standard deviations compared between groups
I Objective assessment of Disease Severity Medical photography and analysis 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
II Assessment of Dermatology Quality of Life 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 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 Responses to the individual questions will be summed and responses compared between groups after unblinding at data analysis
III The investigators anticipate that a large portion of subjects in both groups will ultimately undergo surgery Those that undergo surgery within 4 weeks will be selected for these analyses on the hypothesis that the effect of clascoterone may subside at a longer interval At surgery blinded investigators will measure the left-right cranial-caudal and superficial-deep measurements of the excisional defect with a sterile ruler The investigators will then follow patients with chart review in the electronic medical record for 8 weeks postoperatively to assess for immediate wound complications such as cellulitis wound separation abscess and early recurrence
III Assessment of Cutaneous Inflammation A full thickness representative sample of the excised pilonidal cyst and adjacent normal tissue will be obtained at operation fixed in formalin and delivered to the skin phenomics core of the University of Pennsylvania Skin Biology Disease Research Core SBDRC Following de-paraffination rehydration antigen retrieval and blocking as necessary SBDRC-validated antibodies will be applied to characterize the inflammatory infiltrate specifically anti- CD3 T- cells and Natural Killer Cells anti-CD4 helper T-cells anti-CD8 cytotoxic T-cells anti-CD68 macrophages anti-CD79 B cells Investigators blinded to treatment groups will assess the specimens for epidermal dermal and subcuticular inflammatory infiltrates hyperkeratosis and follicular hyperplasia Antibody-positive cells will be counted in six randomly selected fields under a light microscope at 400x magnification Cell counts will be tallied and means and standard deviations compared between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None