Effectiveness of Laser Hair Removal in Pilonidal Disease

Nationwide Children's Hospital

Status: Active, not recruiting

Conditions: Pilonidal Disease

Treatments: Device: Laser depilation; Other: Standard of care hair depilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03276065

IRB17-00186

Details and patient eligibility

About

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.

Enrollment: 302 estimated patients

Sex: All

Ages: 11 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Laser plus Standard of Care Depilation

Experimental group

Description:

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.

Treatment:

Device: Laser depilation

Standard of Care Depilation

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care hair depilation