Effectiveness of Laser Hair Removal in Pilonidal Disease

NCT03276065 | Unknown FDA Device

• 1 other identifier: IRB17-00186
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Disability Days

  12 months

• Health related quality of life

  1 year

Study Arms (2)

Laser plus Standard of Care Depilation

EXPERIMENTAL

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.

Device: Laser depilation

Standard of Care Depilation

ACTIVE COMPARATOR

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.

Other: Standard of care hair depilation

Interventions

Laser depilation DEVICE

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.

Laser plus Standard of Care Depilation

Standard of care hair depilation OTHER

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.

Standard of Care Depilation

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All Fitzpatrick skin types
• years of age
• Diagnosis of pilonidal disease

You may not qualify if:

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• Minneci PC, Gil LA, Cooper JN, Asti L, Nishimura L, Lutz CM, Deans KJ. Laser Epilation as an Adjunct to Standard Care in Reducing Pilonidal Disease Recurrence in Adolescents and Young Adults: A Randomized Clinical Trial. JAMA Surg. 2024 Jan 1;159(1):19-27. doi: 10.1001/jamasurg.2023.5526.

  PMID: 37938854 DERIVED

• Minneci PC, Halleran DR, Lawrence AE, Fischer BA, Cooper JN, Deans KJ. Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial. Trials. 2018 Nov 1;19(1):599. doi: 10.1186/s13063-018-2987-7.

  PMID: 30382903 DERIVED

Study Officials

• Peter C Minneci, MD, MHSc

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Katherine J Deans, MD, MHSc

  Nationwide Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery and Pediatrics

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: September 5, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)