NCT03276065

Effectiveness of Laser Hair Removal in Pilonidal Disease

Randomized Controlled Trial of Laser Hair Depilation in Adolescents With Pilonidal Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 302 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 11 Years – 21 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-09-05
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-09-08
• Last updated: 2022-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study