Effectiveness of Laser Hair Removal in Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03276065
• Other study ID #: IRB17-00186
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pilonidal disease	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.	12 months
Secondary	Disability Days	Defined as days that patient does participate in all normal activities due to their pilonidal disease	12 months
Secondary	Health related quality of life	Measured using PedsQL scales	1 year