Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laser Hair Removal for Treatment of Pilonidal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949140
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Syneron Candela
Information provided by (Responsible Party):
University of Wisconsin, Madison

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

Condition or disease Intervention/treatment Phase
Pilonidal Disease Procedure: Laser hair removal Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laser Hair Removal for Primary Treatment of Pilonidal Disease Requiring Surgical Intervention
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

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 Name: Laser depilation




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949140


Locations
Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Syneron Candela
Publications:

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03949140    
Other Study ID Numbers: 2018-1031
Protocol Version 6 ( Other Identifier: UW Madison )
A539790 ( Other Identifier: UW Madison )
SMPH/SURGERY/PEDIATRIC SURGERY ( Other Identifier: UW Madison )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No