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Effectiveness of Laser Hair Removal in Pilonidal Disease

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ClinicalTrials.gov Identifier: NCT03276065
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Minneci, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Pilonidal Disease Device: Laser depilation Other: Standard of care hair depilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laser Hair Depilation in Adolescents With Pilonidal Disease
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Recurrence of pilonidal disease [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Disability Days [ Time Frame: 12 months ]
    Defined as days that patient does participate in all normal activities due to their pilonidal disease

  2. Health related quality of life [ Time Frame: 1 year ]
    Measured using PedsQL scales



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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Fitzpatrick skin types
  • 12-20 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276065


Contacts
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Contact: Amy E. Lawrence, MD 614-722-2854 Amy.Lawrence@nationwidechildrens.org
Contact: Devin R. Halleran, MD 614-722-3881 Devin.Halleran@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Amy E. Lawrence, MD    614-722-2854    Amy.Lawrence@nationwidechildrens.org   
Contact: Devin R. Halleran, MD    614-722-3881    Devin.Halleran@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Peter C Minneci, MD, MHSc Nationwide Children's Hospital
Study Director: Katherine J Deans, MD, MHSc Nationwide Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Minneci, Associate Professor of Surgery and Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03276065     History of Changes
Other Study ID Numbers: IRB17-00186
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No