<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03276065</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-00186</org_study_id>
    <nct_id>NCT03276065</nct_id>
  </id_info>
  <brief_title>Effectiveness of Laser Hair Removal in Pilonidal Disease</brief_title>
  <official_title>Randomized Controlled Trial of Laser Hair Depilation in Adolescents With Pilonidal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilonidal disease is a common painful condition that affects 26 per 100,000 people with an&#xD;
      incidence of 1.1% in the young male population. Recurrence rates of pilonidal disease after&#xD;
      initial incision and drainage and after resection have been reported to be 16% and 11%&#xD;
      respectively. Furthermore, wound issues after resection with primary closure have been&#xD;
      reported to be as high as 30%. In several retrospective studies and small prospective&#xD;
      studies, laser hair removal has shown promise as an adjunct therapy to decrease recurrent&#xD;
      infections and decrease the need for repeat surgery in adults and older adolescents. We are&#xD;
      performing a randomized control trial of laser hair depilation plus chemical/mechanical&#xD;
      depilation to examine outcomes related to recurrence of pilonidal disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of pilonidal disease</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability Days</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as days that patient does participate in all normal activities due to their pilonidal disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Measured using PedsQL scales</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">302</enrollment>
  <condition>Pilonidal Disease</condition>
  <arm_group>
    <arm_group_label>Laser plus Standard of Care Depilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Depilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser depilation</intervention_name>
    <description>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.</description>
    <arm_group_label>Laser plus Standard of Care Depilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care hair depilation</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard of Care Depilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All Fitzpatrick skin types&#xD;
&#xD;
          -  11-21 years of age&#xD;
&#xD;
          -  Diagnosis of pilonidal disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of photosensitivity&#xD;
&#xD;
          -  Actively inflamed pilonidal sinus. These patients are invited to participate upon&#xD;
             resolution of their inflamed sinus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter C Minneci, MD, MHSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine J Deans, MD, MHSc</last_name>
    <role>Study Director</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Peter Minneci</investigator_full_name>
    <investigator_title>Associate Professor of Surgery and Pediatrics</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03276065
org study id: IRB17-00186
nct id: NCT03276065
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence of pilonidal disease
time frame: 12 months
description: 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.
measure: Disability Days
time frame: 12 months
description: Defined as days that patient does participate in all normal activities due to their pilonidal disease
measure: Health related quality of life
time frame: 1 year
description: Measured using PedsQL scales
arm group label: Laser plus Standard of Care Depilation
arm group type: Experimental
description: 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.
arm group label: Standard of Care Depilation
arm group type: Active Comparator
description: 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: Device
intervention name: Laser depilation
description: 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.
arm group label: Laser plus Standard of Care Depilation
intervention type: Other
intervention name: Standard of care hair depilation
description: 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.
arm group label: Standard of Care Depilation
criteria: 
gender: All
minimum age: 11 Years
maximum age: 21 Years
healthy volunteers: No
last name: Peter C Minneci, MD, MHSc
role: Principal Investigator
affiliation: Nationwide Children's Hospital
last name: Katherine J Deans, MD, MHSc
role: Study Director
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Peter Minneci
investigator title: Associate Professor of Surgery and Pediatrics