Laser Hair Removal for Treatment of Pilonidal Disease

December 16, 2021 updated by: University of Wisconsin, Madison

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser hair removal treatment
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
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.
Other Names:
  • Laser depilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of disease-free remission
Time Frame: up to 2 years
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.
Time Frame: up to 2 years
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.
Time Frame: up to 2 years
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
Time Frame: Up to 18 months
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
Time Frame: up to 18 months
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
Time Frame: up to 18 months
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.
Time Frame: up to 2 years
Evaluate total cost to the health care system relative to period of disease-free remission.
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Syneron Candela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-1031
  • Protocol Version 6 (Other Identifier: HS-IRB UW Madison)
  • A539790 (Other Identifier: UW Madison)
  • SMPH/SURGERY/PEDIATRIC SURGERY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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