Pilot Study of Laser Hair Depilation for Pilonidal Disease

NCT ID: NCT02778152

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-19
• Study Completion Date: 2018-02-02

Brief Summary

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

Detailed Description

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.

Conditions

Pilonidal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser depilation

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.

Group Type: EXPERIMENTAL

Laser depilation

Intervention Type: DEVICE

Laser depilation of natal cleft (pilonidal region)

Interventions

Laser depilation

Laser depilation of natal cleft (pilonidal region)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peter Minneci

OTHER

Sponsor Role: lead

Responsible Party

Peter Minneci

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter C Minneci, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute at Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-00104

Identifier Type: -

Identifier Source: org_study_id