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
(i.e. spironolactone). At the intake visit, patients will undergo a 1:1 randomization
performed by the University of Pennsylvania's 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.