Effectiveness of Laser Hair Removal in Pilonidal Disease

Not Applicable

• Conditions: Pilonidal Disease
• Interventions: Device: Laser depilation; Other: Standard of care hair depilation

• Registration Number: NCT03276065
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• All Fitzpatrick skin types
• 11-21 years of age
• Diagnosis of pilonidal disease

Exclusion Criteria

• History of photosensitivity
• Actively inflamed pilonidal sinus. These patients are invited to participate upon resolution of their inflamed sinus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser plus Standard of Care Depilation	Laser depilation	Laser depilation to the natal cleft (pilonidal region) every 4-6 weeks for 5 treatments with either an 810nm or Nd:YAG laser dependent on Fitzpatrick skin type and tolerability. Patients and families in the intervention group will also be taught hair removal techniques and asked to perform either chemical or mechanical depilation as needed to keep the area hair-free between clinic treatments.
Standard of Care Depilation	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.

Primary Outcome Measures

Name	Time	Method
Recurrence of pilonidal disease	12 months	Recurrence is defined as a new development of pilonidal abscess, folliculitis, or draining sinus after treatment which would require antibiotic treatment, additional surgical incision and drainage or excision.

Secondary Outcome Measures

Name	Time	Method
Disability Days	12 months	Defined as days that patient does participate in all normal activities due to their pilonidal disease
Health related quality of life	1 year	Measured using PedsQL scales

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States