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Effectiveness of Laser Hair Removal in Pilonidal Disease

NCT03276065 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2022-07-25

No results posted yet for this study

Summary

Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after initial incision and drainage and after resection have been reported to be 16% and 11% respectively. Furthermore, wound issues after resection with primary closure have been reported to be as high as 30%. In several retrospective studies and small prospective studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent infections and decrease the need for repeat surgery in adults and older adolescents. We are performing a randomized control trial of laser hair depilation plus chemical/mechanical depilation to examine outcomes related to recurrence of pilonidal disease.

Conditions

  • Pilonidal Disease

Interventions

DEVICE

Laser depilation

Fitzpatrick skin type classification will be assessed during the initial visit. The Fitzpatrick skin type classification is based on the level of pigmentation of the skin and its response to ultraviolet light (See Appendix). It will be used to select the best laser to perform hair removal for each patient. The laser treatment group will consist of an 810 nm (for Fitzpatrick skin types I-IV) or Nd:YAG (for Fitzpatrick skin types V-VI) 28 joule application at auto pulse duration for 400 ms. A cooling platform and application of 7% lidocaine/ 7% tetracaine cream, applied 45 minutes prior to treatment, will minimize any discomfort associated with the heat of the laser treatments.

OTHER

Standard of care hair depilation

Patients and families in the standard of care group will be taught hair removal techniques and asked to perform either chemical or mechanical depilation as needed to keep the area hair-free. Patients will be given supplies for six months of hair removal.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Peter C Minneci, MD, MHSc · Nationwide Children's Hospital

  • Katherine J Deans, MD, MHSc · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03276065 on ClinicalTrials.gov