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Completed

NCT Number: NCT03949140

Laser Hair Removal for Treatment of Pilonidal Disease

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

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Key information

Conditions

Pilonidal Disease

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser hair removal

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Syneron Candela

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 14, 2019
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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