Effectiveness of Laser Hair Removal in Pilonidal Disease

NCT ID: NCT03276065

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser plus Standard of Care 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.

Group Type: EXPERIMENTAL

Laser depilation

Intervention Type: 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.

Standard of Care 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.

Group Type: ACTIVE_COMPARATOR

Standard of care hair depilation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Minneci

Associate Professor of Surgery and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter C Minneci, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Katherine J Deans, MD, MHSc

Role: STUDY_DIRECTOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37938854 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30382903 (View on PubMed)

Other Identifiers

IRB17-00186

Identifier Type: -

Identifier Source: org_study_id