Pilot Study of Laser Hair Depilation for Pilonidal Disease

Study Overview
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Brief Summary
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Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.

Detailed Description
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This is a pilot study to measure safety and tolerance of laser hair depilation in adolescents and young adults with pilonidal disease as a potential treatment to intervene on future recurrence. Up to a total of 10 patients will be enrolled. Each patient will be involved in the study for one year. Patients will be brought into Surgery clinic for 1 laser treatment every 4-6 weeks to obtain a total of 5 treatments. Follow up will occur monthly from the time of initial treatment through 1 year after the last treatment as we evaluate for tolerance and efficacy. Inclusion Criteria English and non-English speaking patients All Fitzpatrick skin types Age : 12-20 years Diagnosis of pilonidal disease Exclusion Criteria History of photosensitivity Actively inflamed pilonidal sinus Laser depilation treatment: Patients will be brought into Surgery clinic for 1 treatment every 4-6 weeks to obtain a total of 5 treatments. The treatment will consist of an 810 nm or Nd:YAG depending on Fitzpatrick skin type and tolerability. A cooling platform and application of topical lidocaine cream will be used to minimize any discomfort associated with the heat of the laser treatments. Initial follow up for the laser depilation group will be performed to assess for tolerance of the laser treatment. Patients will report their pain every 6 hours for the first 48 hours after their laser hair depilation treatment. Once tolerance is established, patients will return to surgical clinic every month for their laser or placebo visit. After the 5th clinic visit, they will receive a telephone call monthly to assess for any evidence of resolution or recurrence of disease up to 1 year after the completion of the treatments.

Official Title
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Pilonidal Disease Laser Depilation Pilot Study

Conditions
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Pilonidal Disease

Intervention / Treatment
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* Device: Laser depilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English and non-English speaking patients All Fitzpatrick skin types Age : 12-20 years Diagnosis of pilonidal disease Exclusion Criteria: History of photosensitivity Actively inflamed pilonidal sinus

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 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
Interventional Model Description: Laser hair removal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser depilation<br>Laser depilation to the natal cleft (pilonidal region) monthly for 5 treatments with either an 810nm of Nd:YAG laser dependent on Fitzpatrick skin type and tolerability. | Device: Laser depilation<br>* Laser depilation of natal cleft (pilonidal region)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Laser Treatment | Median of pain scores immediately post-laser treatment after each of the 5 treatments. Pain was assessed on a scale of 1 to 10, 10 being the greatest amount of pain. | five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Second Degree Burns Post-Treatment | Incidence of skin burn within the first 48 hours after each of the 5 treatments | five months |