Laser Hair Removal for Treatment of Pilonidal Disease

Study Overview
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Brief Summary
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This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.

Detailed Description
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This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.

Official Title
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Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention

Conditions
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Pilonidal Disease

Intervention / Treatment
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* Procedure: Laser hair removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention: Experience two or more episodes of infection or abscess in the past 12 months Have pain or drainage for a total of more than 1 month in the past 12 months Missed a total of more than 1 week of school or work in the past 12 months English-speaking Exclusion Criteria: Patients who have co-morbidities that prevent them from becoming a surgical candidate Previous history of laser hair removal in the gluteal cleft (prior to initial enrollment) Previous excision of pilonidal sinus (prior to initial enrollment) Non-English speaking

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser hair removal treatment<br>Patients who choose to enroll will plan to undergo a total of up to 8 laser hair removal sessions every 4-6 weeks. If patients develop abscess or infection during this time, they will undergo I&D and/or antibiotics, consistent with standard therapy for infection or abscess. If patients have 2 or more infections in 1 year, pain or drainage for more than 1 month, or miss more than 1 week of school or work due to ineffective treatment of pilonidal disease, these patients will undergo surgical excision and subsequent follow-up at surgeon's discretion. Patients will follow up at 2-4-week intervals for 3 months, then at 6, 9, and 18 months after conclusion of the laser therapy sessions. At all follow-up sessions, patients will be given the DQLI, CDQLI, and Promis 3A Pain survey. Unscheduled visits such as unplanned clinic visits, emergency department encounters, and hospitalizations, will be included in data collected for analysis of primary and secondary outcomes. | Procedure: Laser hair removal<br>* Those who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks.<br>* Other names: Laser depilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of disease-free remission | Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months. | up to 2 years | 
| Disease recurrence rate among subjects who subsequently require surgical intervention. | Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the degree of intervention required to obtain positive results. | Incision and drainage vs. need for larger excision, requirement for oral antibiotics, and the number of emergency room visits, or hospital admissions related to pilonidal disease. | up to 2 years | 
| Number of missed school or work days | This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months. | Up to 18 months | 
| Assessment of Pain via Promis 3A Pain Short Form | This study will investigate qualitative outcomes including pain. Pain will be assessed via the Promis 3A Pain Short Form at 6, 9, and 18 months. This is a one question survey that has participants rate the intensity of their pain over the last 7 days, on average. The scale is from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | up to 18 months | 
| Number of Days Participants Experience Drainage | This study will investigate qualitative outcomes including assessment of drainage. This will be reported as the number of days participants experienced drainage since last follow up, assessed at 6, 9, and 18 month follow up. | up to 18 months | 
| Cost-benefit analysis of laser hair-treated patients versus matched historical control. | Evaluate total cost to the health care system relative to period of disease-free remission. | up to 2 years |