<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/NCT03240718</url>
  </required_header>
  <id_info>
    <org_study_id>CE14-122</org_study_id>
    <nct_id>NCT03240718</nct_id>
  </id_info>
  <brief_title>Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients</brief_title>
  <official_title>Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, controlled, within-patient, single-blinded, pilot study that will&#xD;
      evaluate the impact of laser treatment on burn HSc relative to self-matched control scars.&#xD;
      The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain,&#xD;
      itch and patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior to treatment initiation, two independent scars sites will be selected and an&#xD;
      anatomically- on each individual. At the selected treatment site the scar will be treated&#xD;
      with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4&#xD;
      weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd&#xD;
      treatment and 12 weeks after their final treatment session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin Characteristics changes</measure>
    <time_frame>baseline, 12 weeks and 24 weeks</time_frame>
    <description>Erythema, elasticity and thickness measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Questionnaire</measure>
    <time_frame>baseline, 24 weeks</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Laser treated HSc scar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Co2 laser treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control scar</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser treatment</intervention_name>
    <description>CORE fractional CO2 laser treatment</description>
    <arm_group_label>Laser treated HSc scar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fitzpatrick skin type &lt;IV (37),&#xD;
&#xD;
          -  Have sustained a thermal burn injury,&#xD;
&#xD;
          -  Have at least 2 independent sites that show clinical evidence of HSc,&#xD;
&#xD;
          -  Are 2 months or more post-injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with skin phototypes IV or higher,&#xD;
&#xD;
          -  With history of keloidal scarring,&#xD;
&#xD;
          -  Who have coagulation disorder,&#xD;
&#xD;
          -  Are taking immunosuppressive medications,&#xD;
&#xD;
          -  If the mechanism of injury is an electrical, chemical, or cold injury,&#xD;
&#xD;
          -  Any underlying active skin disease,&#xD;
&#xD;
          -  Have taken oral Isotreinoin within the last 6 months,&#xD;
&#xD;
          -  Photosensitivity or have taken photosensitizing medications,&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernadette Nedelec, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRCHUM</affiliation>
  </overall_official>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>February 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix, Hypertrophic</mesh_term>
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03240718
org study id: CE14-122
nct id: NCT03240718
lead sponsor: 
has dmc: No
This is a randomized, controlled, within-patient, single-blinded, pilot study that will
      evaluate the impact of laser treatment on burn HSc relative to self-matched control scars.
      The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain,
      itch and patient satisfaction.
Prior to treatment initiation, two independent scars sites will be selected and an
      anatomically- on each individual. At the selected treatment site the scar will be treated
      with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4
      weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd
      treatment and 12 weeks after their final treatment session.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Skin Characteristics changes
time frame: baseline, 12 weeks and 24 weeks
description: Erythema, elasticity and thickness measures
measure: Satisfaction Questionnaire
time frame: baseline, 24 weeks
description: Questionnaire
arm group label: Laser treated HSc scar
arm group type: Experimental
description: Co2 laser treatment
arm group label: Control scar
arm group type: No Intervention
description: Standard care
intervention type: Procedure
intervention name: Laser treatment
description: CORE fractional CO2 laser treatment
arm group label: Laser treated HSc scar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bernadette Nedelec, PhD
role: Principal Investigator
affiliation: CRCHUM
responsible party type: Sponsor
mesh term: Cicatrix, Hypertrophic
mesh term: Burns
sharing ipd: Yes