<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/NCT02988622</url>
  </required_header>
  <id_info>
    <org_study_id>201509722</org_study_id>
    <nct_id>NCT02988622</nct_id>
  </id_info>
  <brief_title>Comparison of Lasers in the Treatment of Scars</brief_title>
  <official_title>1550-nm Non Ablative Laser (Fraxel) Versus Ablative 10,600-nm Carbon Dioxide (CO2) Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy, Treatment Regimen, and Cost.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marta Hemmingson-Van Beek</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as&#xD;
      Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser&#xD;
      (referred to as CO2 Laser in this application) to determine if one is superior to the other&#xD;
      in improving the appearance of scars over a series of three treatments. In addition, the&#xD;
      investigators hope to identify a more cost-effective method to improve the appearance of&#xD;
      scars caused by surgery or trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be accomplished through a controlled split-scar study design whereby half of&#xD;
      the scar will be treated with the Fraxel Laser and the other half of the scar will be treated&#xD;
      with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study&#xD;
      whereby 100 participants will be recruited, enrolled and followed for a period of 9 months.&#xD;
      The study population will include male and female participants, age 18 and over with scars&#xD;
      secondary to surgery or trauma on any part of the body. The study will recruit participants&#xD;
      with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly&#xD;
      higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to&#xD;
      accommodate for the split-scar treatment. The participants will undergo laser treatments on&#xD;
      Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will&#xD;
      return for evaluation and follow-up 3 months and 6 months following the last laser treatment.&#xD;
      At each visit, photographs will be taken using identical camera settings, lighting and&#xD;
      participant positioning. Evaluation of the scars will be completed by the participants and by&#xD;
      blinded dermatology physicians. Participants will use a complete visual analogue scale at&#xD;
      each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scar Pain</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar Itching</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar Color</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar Stiffness</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar Thickness</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scar Irregularity</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Opinion</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Patients rated how satisfied they were with the appearance of each half of the treated scar.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Observer Total Score</measure>
    <time_frame>Baseline and 6 months.</time_frame>
    <description>Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Scar</condition>
  <arm_group>
    <arm_group_label>Scar treated with Fraxel and CO2 laser</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fraxel Laser</intervention_name>
    <description>One half of the scar is treated with Fraxel Laser</description>
    <arm_group_label>Scar treated with Fraxel and CO2 laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CO2 Laser</intervention_name>
    <description>One half of the scar is treated with CO2 Laser.</description>
    <arm_group_label>Scar treated with Fraxel and CO2 laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 or older.&#xD;
&#xD;
          2. Fitzpatrick skin type I-IV.&#xD;
&#xD;
          3. Scars secondary to surgery or trauma.&#xD;
&#xD;
          4. Scar length minimum 4 cm in length.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Scars less than 6 weeks old.&#xD;
&#xD;
          2. History of keloid scarring.&#xD;
&#xD;
          3. Use of isotretinoin currently or within 3 months of enrollment&#xD;
&#xD;
          4. Use of photosensitive medication currently or within 3 months of enrollment.&#xD;
&#xD;
          5. Pregnancy -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pooja Chitogopeker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Health Care, Department of Dermatology</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>August 29, 2017</results_first_submitted>
  <results_first_submitted_qc>December 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2017</results_first_posted>
  <last_update_submitted>September 20, 2018</last_update_submitted>
  <last_update_submitted_qc>September 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Marta Hemmingson-Van Beek</investigator_full_name>
    <investigator_title>Sponsor Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02988622/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02988622/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>100 patients were recruited from the University of Iowa, Hospitals and Clinics between June to August 2016.</recruitment_details>
      <pre_assignment_details>The exclusion criteria included any scar less than 6 weeks old, a history of keloid scarring, use of isotretinoin or other photosensitizing medication at the time of the study or within the previous 3 months and if the patient was pregnant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Scar is Treated With Fraxel Laser and CO2 Laser</title>
          <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser&#xD;
CO2 Laser: One half of the scar is treated with CO2 Laser.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Scar is Treated With Fraxel Laser and CO2 Laser</title>
          <description>Fraxel Laser: One half of the scar is treated with Fraxel Laser&#xD;
CO2 Laser: One half of the scar is treated with CO2 Laser.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.8" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Scar age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.7" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Scar length</title>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Scar Pain</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Pain</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.265" spread="0.938"/>
                    <measurement group_id="O2" value="1.181" spread="0.608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.048" spread="0.215"/>
                    <measurement group_id="O2" value="1.084" spread="0.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0492</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.1205</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.5499</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scar Itching</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Itching</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.386" spread="0.853"/>
                    <measurement group_id="O2" value="1.337" spread="0.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.084" spread="0.568"/>
                    <measurement group_id="O2" value="1.277" spread="1.140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0817</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2410</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.0817</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scar Color</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Color</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.622" spread="2.623"/>
                    <measurement group_id="O2" value="5.518" spread="2.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.108" spread="2.078"/>
                    <measurement group_id="O2" value="4.313" spread="2.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0686</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3659</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.7951</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scar Stiffness</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Stiffness</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.361" spread="2.770"/>
                    <measurement group_id="O2" value="4.518" spread="2.856"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.313" spread="2.112"/>
                    <measurement group_id="O2" value="3.386" spread="2.094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6278</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.0843</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.5789</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scar Thickness</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Thickness</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.325" spread="2.785"/>
                    <measurement group_id="O2" value="5.145" spread="2.833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.373" spread="1.943"/>
                    <measurement group_id="O2" value="3.530" spread="2.086"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0848</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3373</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.7619</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Scar Irregularity</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Scar Irregularity</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.602" spread="2.888"/>
                    <measurement group_id="O2" value="6.500" spread="2.616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3964" spread="2.167"/>
                    <measurement group_id="O2" value="4.084" spread="2.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3418</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2195</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.0788</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Opinion</title>
        <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Patients with available data at the 6-month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Opinion</title>
          <description>Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.</description>
          <population>Patients with available data at the 6-month time point.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.695" spread="2.215"/>
                    <measurement group_id="O2" value="6.654" spread="2.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.024" spread="2.049"/>
                    <measurement group_id="O2" value="4.207" spread="2.187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1752</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.2375</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.5528</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction</title>
        <description>Patients rated how satisfied they were with the appearance of each half of the treated scar.</description>
        <time_frame>6 months</time_frame>
        <population>Participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patients rated how satisfied they were with the appearance of each half of the treated scar.</description>
          <population>Participants with available data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Very dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat dissatisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Satisfied</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Observer Total Score</title>
        <description>Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).</description>
        <time_frame>Baseline and 6 months.</time_frame>
        <population>Patients with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Scar is Treated With Fraxel Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
          </group>
          <group group_id="O2">
            <title>Scar Treated With CO2 Laser</title>
            <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
          </group>
        </group_list>
        <measure>
          <title>Observer Total Score</title>
          <description>Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).</description>
          <population>Patients with available data.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3238" spread="1.9781"/>
                    <measurement group_id="O2" value="0.0586" spread="2.0552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0281</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.3824</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.5685</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Scar is Treated With Fraxel Laser</title>
          <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with Fraxel Laser</description>
        </group>
        <group group_id="E2">
          <title>Scar Treated With CO2 Laser</title>
          <description>Each patient received treatment with both lasers to separate halves of their scar.&#xD;
Fraxel Laser: One half of the scar is treated with CO2 Laser</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blistering</sub_title>
                <description>Superficial blisters on the skin following treatment with CO2 and Fraxel laser</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This is the largest split scar study comparing the C02 laser and Fraxel laser, however despite this the numbers are still relatively small overall. 100 patients were enrolled in teh study but only 83 completed the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Marta VanBeek</name_or_title>
      <organization>Univeristy of Iowa, Hospitals and Clinics</organization>
      <phone>(319) 384-6012</phone>
      <email>marta-vanbeek@uiowa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02988622
org study id: 201509722
nct id: NCT02988622
lead sponsor: 
has dmc: No
is fda regulated device: Yes
The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as
      Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser
      (referred to as CO2 Laser in this application) to determine if one is superior to the other
      in improving the appearance of scars over a series of three treatments. In addition, the
      investigators hope to identify a more cost-effective method to improve the appearance of
      scars caused by surgery or trauma.
This study will be accomplished through a controlled split-scar study design whereby half of
      the scar will be treated with the Fraxel Laser and the other half of the scar will be treated
      with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study
      whereby 100 participants will be recruited, enrolled and followed for a period of 9 months.
      The study population will include male and female participants, age 18 and over with scars
      secondary to surgery or trauma on any part of the body. The study will recruit participants
      with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly
      higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to
      accommodate for the split-scar treatment. The participants will undergo laser treatments on
      Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will
      return for evaluation and follow-up 3 months and 6 months following the last laser treatment.
      At each visit, photographs will be taken using identical camera settings, lighting and
      participant positioning. Evaluation of the scars will be completed by the participants and by
      blinded dermatology physicians. Participants will use a complete visual analogue scale at
      each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Scar Pain
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Scar Itching
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Scar Color
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Scar Stiffness
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Scar Thickness
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Scar Irregularity
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Overall Opinion
time frame: Baseline and 6 months
description: Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
measure: Patient Satisfaction
time frame: 6 months
description: Patients rated how satisfied they were with the appearance of each half of the treated scar.
measure: Observer Total Score
time frame: Baseline and 6 months.
description: Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).
arm group label: Scar treated with Fraxel and CO2 laser
arm group type: Other
description: One half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser.
intervention type: Device
intervention name: Fraxel Laser
description: One half of the scar is treated with Fraxel Laser
arm group label: Scar treated with Fraxel and CO2 laser
intervention type: Device
intervention name: CO2 Laser
description: One half of the scar is treated with CO2 Laser.
arm group label: Scar treated with Fraxel and CO2 laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pooja Chitogopeker, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Marta Hemmingson-Van Beek
investigator title: Sponsor Investigator
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This is the largest split scar study comparing the C02 laser and Fraxel laser, however despite this the numbers are still relatively small overall. 100 patients were enrolled in teh study but only 83 completed the study.
point of contact: 