Laser Hair Removal for Treatment of Pilonidal Disease

Not Applicable

Completed

• Conditions: Pilonidal Disease
• Interventions: Procedure: Laser hair removal

• Registration Number: NCT03949140
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-11-16
• Study Start: 2019-02-18
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser hair removal treatment	Laser hair removal	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.

Primary Outcome Measures

Name	Time	Method
Incidence of disease-free remission	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.
Disease recurrence rate among subjects who subsequently require surgical intervention.	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

Name	Time	Method
Cost-benefit analysis of laser hair-treated patients versus matched historical control.	up to 2 years	Evaluate total cost to the health care system relative to period of disease-free remission.
Characterization of the degree of intervention required to obtain positive results.	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.
Number of missed school or work days	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.
Assessment of Pain via Promis 3A Pain Short Form	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.
Number of Days Participants Experience Drainage	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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States