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Pilonidal Disease Laser Depilation Pilot Study
Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.
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.
Age
12 - 20 years
Sex
ALL
Healthy Volunteers
No
Nationwide Children's Hospital
Columbus, Ohio, United States
Start Date
February 19, 2016
Primary Completion Date
February 2, 2018
Completion Date
February 2, 2018
Last Updated
March 26, 2019
13
ACTUAL participants
Laser depilation
DEVICE
Lead Sponsor
Peter Minneci
NCT03772873
NCT03534700
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05289297