<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/NCT02985151</url>
  </required_header>
  <id_info>
    <org_study_id>SLU-27403</org_study_id>
    <nct_id>NCT02985151</nct_id>
  </id_info>
  <brief_title>Interventional Study to Evaluate the Appearance of Surgical Scars After Laser Therapy</brief_title>
  <official_title>A Single Center, Double-blinded Randomized Placebo-controlled Trial to Evaluate Surgical Scars After Treatment With Fractional Carbon Dioxide Rejuvenation Laser Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of&#xD;
      the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has&#xD;
      not had laser therapy may be eligible to participate. The visits occur every three months for&#xD;
      up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a&#xD;
      lower energy treatment during the study. Subjects and raters will be blinded to which therapy&#xD;
      level the patient receives. At each visit, the scars will be photographed and the subject&#xD;
      will complete a questionnaire to rate the scar prior to treatment. Three physicians will&#xD;
      evaluate the scar at each visit. One rater will evaluate the scars in person during the&#xD;
      visit, while the other two raters will evaluate the scars using photographs after each visit.&#xD;
      During the first three study visits, subjects will receive their assigned treatment, obtain&#xD;
      post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other&#xD;
      skin changes after treatment. At the third study visit, subjects will have the option to&#xD;
      receive additional treatments or terminate their participation in the study. The fourth visit&#xD;
      for those who continue will be a treatment visit for one group and the fifth visit will be&#xD;
      for data collection, with no treatment offered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In dermatology, the use of Light Amplification by Stimulated Emission of Radiation (laser)&#xD;
      has revolutionized the management of various conditions including angiomas, vitiligo,&#xD;
      wrinkles, and scars. (Omi, 2014 and Chapas, 2008) Scars result from sub-optimal collagen&#xD;
      production during wound healing leading to topographical irregularities. To effectively&#xD;
      modify these defects, any treatment must be capable of penetrating the epidermis and&#xD;
      eliciting dermal remodeling at a depth of at least 1 mm. The 10,600 nm carbon dioxide (CO2)&#xD;
      laser utilizes high energy at short durations to vaporize intra- and extra-cellular water,&#xD;
      resulting in tissue ablation causing a substantial thermal injury to the dermis, reducing the&#xD;
      likelihood of additional scarring. The CO2 laser can stimulate collagen production and&#xD;
      theoretically improve scar thickness, pliability, and texture.&#xD;
&#xD;
      This study is a prospective, randomized double-blinded placebo-controlled trial to evaluate&#xD;
      the efficacy of fractionated carbon dioxide laser in improving surgical scars on the head and&#xD;
      neck over 3-5 study visits for a duration of 12.5 months. Scar assessments will be based on&#xD;
      objective changes identified on pictures taken with the Canfield Vectra M3 3D Imaging System&#xD;
      and subjective changes identified with the Patient and Observer Scar Assessment Scale&#xD;
      (POSAS), a validated scar scale. As a secondary objective, the study will evaluate the&#xD;
      tolerability of the laser, by assessing the severity and duration of known side effects of&#xD;
      laser therapy such as erythema, edema, burning sensation, post-inflammatory pigment changes,&#xD;
      infection, scarring, xerosis, pruritus, bronzing, and any other adverse events that arise&#xD;
      following treatment. Subjects will be given a diary after each treatment to document this&#xD;
      information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a crossover study where subjects are randomized into two arms. Subjects in the sham arm are allowed to crossover at the end of their initial intervention period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>3 months (month 0-3 for original randomized group, month 6-9 for crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>3 months (month 0-3 for original randomized group, month 6-9 for crossover group)</time_frame>
    <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</measure>
    <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</measure>
    <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</measure>
    <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
    <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</measure>
    <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
    <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
    <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</measure>
    <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
    <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group</measure>
    <time_frame>V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group</time_frame>
    <description>Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment. Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable). The average weekly score for each group is reported below.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Cicatrix</condition>
  <condition>Carbon Dioxide Laser</condition>
  <arm_group>
    <arm_group_label>High Energy Treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group will be offered a third optional treatment at one of these settings.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Energy Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high energy treatments subsequent to receiving the two light energy treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Syneron-Candela CO2RE Laser</intervention_name>
    <description>This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.</description>
    <arm_group_label>High Energy Treatment Group</arm_group_label>
    <arm_group_label>Low Energy Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical scar present in the head or neck region for at least 8 weeks.&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
          -  Available for study appointments&#xD;
&#xD;
          -  Follows directions of post-treatment instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals under the age of 18&#xD;
&#xD;
          -  Prior laser treatment to the head or neck&#xD;
&#xD;
          -  History of keloid formation&#xD;
&#xD;
          -  Isotretinoin use in the last 6 months prior to study enrollment&#xD;
&#xD;
          -  Allergy to topical lidocaine&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramona Behshad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis University, Department of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University Department of Dermatology-Des Peres Med Arts Pavilion II</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.</citation>
    <PMID>24771971</PMID>
  </reference>
  <reference>
    <citation>Bodendorf MO, Grunewald S, Wetzig T, Simon JC, Paasch U. Fractional laser skin therapy. J Dtsch Dermatol Ges. 2009 Apr;7(4):301-8. doi: 10.1111/j.1610-0387.2008.06845.x. Epub 2008 Aug 28. English, German.</citation>
    <PMID>18761608</PMID>
  </reference>
  <reference>
    <citation>Chapas AM, Brightman L, Sukal S, Hale E, Daniel D, Bernstein LJ, Geronemus RG. Successful treatment of acneiform scarring with CO2 ablative fractional resurfacing. Lasers Surg Med. 2008 Aug;40(6):381-6. doi: 10.1002/lsm.20659.</citation>
    <PMID>18649382</PMID>
  </reference>
  <reference>
    <citation>Majid I, Imran S. Fractional CO2 Laser Resurfacing as Monotherapy in the Treatment of Atrophic Facial Acne Scars. J Cutan Aesthet Surg. 2014 Apr;7(2):87-92. doi: 10.4103/0974-2077.138326.</citation>
    <PMID>25136208</PMID>
  </reference>
  <reference>
    <citation>van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.</citation>
    <PMID>21598065</PMID>
  </reference>
  <reference>
    <citation>Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.</citation>
    <PMID>15216537</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>February 27, 2023</results_first_submitted>
  <results_first_submitted_qc>June 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2023</results_first_posted>
  <disposition_first_submitted>November 13, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>November 13, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 18, 2021</disposition_first_posted>
  <last_update_submitted>June 3, 2023</last_update_submitted>
  <last_update_submitted_qc>June 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Ramona Behshad, MD</investigator_full_name>
    <investigator_title>Associate Professor, Department of Dermatology</investigator_title>
  </responsible_party>
  <keyword>Scar</keyword>
  <keyword>Carbon Dioxide Laser</keyword>
  <keyword>Laser Ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified participant data may be accessed after publication of the results in a medical journal.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02985151/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT02985151/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>51 patients enrolled in the study. One subject withdrew from the study prior to treatment. A total of 50 subjects received treatment in the study. There were 10 subjects who crossed-over from low-energy treatment to high-energy treatment after completing the low-energy portion of the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>High Energy Treatment Group</title>
          <description>Subjects in this group received one to two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser will administer energy at either a high-intensity setting or a low-intensity setting to subjects randomized into a particular treatment group. It will be operated by the principal investigator, who has extensive experience with laser therapy.</description>
        </group>
        <group group_id="P2">
          <title>Low Energy Placebo Group</title>
          <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Original Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Crossover From Low to High Energy</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>High Energy Treatment Group</title>
          <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
        </group>
        <group group_id="B2">
          <title>Low Energy Placebo Group</title>
          <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.6" spread="9.7"/>
                    <measurement group_id="B2" value="56.3" spread="10.7"/>
                    <measurement group_id="B3" value="58.2" spread="10.1"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scar Length</title>
          <description>Visit 1 scar dimensions measured by Vectra analysis</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.0" spread="17.42809"/>
                    <measurement group_id="B2" value="36.8" spread="27.25163"/>
                    <measurement group_id="B3" value="33.5044" spread="22.13543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scar Width</title>
          <description>Visit 1 scar dimensions measured by Vectra analysis</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.7" spread="10.25"/>
                    <measurement group_id="B2" value="11.6" spread="9.95"/>
                    <measurement group_id="B3" value="11.08" spread="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Scar Surface Area</title>
          <description>Visit 1 scar dimensions measured by Vectra analysis</description>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" spread="2.37"/>
                    <measurement group_id="B2" value="4.4" spread="6.72"/>
                    <measurement group_id="B3" value="3.41" spread="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
        <time_frame>3 months (month 0-3 for original randomized group, month 6-9 for crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.78"/>
                    <measurement group_id="O2" value="0.03" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
        <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
        <time_frame>3 months (month 0-3 for original randomized group, month 6-9 for crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
          <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>score 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="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.29" spread="3.95"/>
                    <measurement group_id="O2" value="-3.30" spread="3.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
        <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.34"/>
                    <measurement group_id="O2" value="-0.08" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.</description>
        <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.11"/>
                    <measurement group_id="O2" value="-0.04" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
        <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="1.18"/>
                    <measurement group_id="O2" value="-0.23" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
        <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.83"/>
                    <measurement group_id="O2" value="-1.37" spread="4.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
        <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.</description>
        <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
          <description>Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.18"/>
                    <measurement group_id="O2" value="-0.05" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
        <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
        <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
          <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>score 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="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.95" spread="2.98"/>
                    <measurement group_id="O2" value="-5.16" spread="5.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
        <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
        <time_frame>3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group</title>
          <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>score 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="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="3.51"/>
                    <measurement group_id="O2" value="-2.73" spread="2.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
        <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
        <time_frame>6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group</title>
          <description>Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.</description>
          <units>score 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="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.18" spread="4.38"/>
                    <measurement group_id="O2" value="-4.28" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group</title>
        <description>Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment. Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable). The average weekly score for each group is reported below.</description>
        <time_frame>V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group</time_frame>
        <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
        <group_list>
          <group group_id="O1">
            <title>High Energy Treatment Group</title>
            <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
          <group group_id="O2">
            <title>Low Energy Placebo Group</title>
            <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group</title>
          <description>Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment. Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable). The average weekly score for each group is reported below.</description>
          <population>The high-energy treatment group includes the 25 participants originally randomized to high-energy treatment and the 10 crossover subjects. The low-energy placebo group includes the 25 subjects who did not withdraw from the study (26 were originally randomized, and one withdrew).</population>
          <units>score 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="35"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient Diary Redness After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" spread="0.73"/>
                    <measurement group_id="O2" value="1.98" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Scaling After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.62"/>
                    <measurement group_id="O2" value="0.70" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Pustules After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="0.67"/>
                    <measurement group_id="O2" value="0.29" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Swelling After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="0.90"/>
                    <measurement group_id="O2" value="0.99" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Pain After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.54"/>
                    <measurement group_id="O2" value="0.62" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Itch After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.59"/>
                    <measurement group_id="O2" value="0.64" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Burn After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.44"/>
                    <measurement group_id="O2" value="0.59" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Color After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.90"/>
                    <measurement group_id="O2" value="0.95" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Infection After Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.19"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Redness After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="0.77"/>
                    <measurement group_id="O2" value="2.00" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Scaling After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="0.70"/>
                    <measurement group_id="O2" value="0.95" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Pustules After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.67"/>
                    <measurement group_id="O2" value="0.58" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Swelling After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="0.90"/>
                    <measurement group_id="O2" value="1.04" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Pain After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.58" spread="0.74"/>
                    <measurement group_id="O2" value="0.66" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Itch After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.50"/>
                    <measurement group_id="O2" value="1.23" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Burn After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="0.66"/>
                    <measurement group_id="O2" value="0.65" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Color After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="0.81"/>
                    <measurement group_id="O2" value="0.64" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patient Diary Infection After Visit 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.06"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected at each study visit (spaced 3 months apart) over a period of up to 12 months for each subject.</time_frame>
      <desc>Systematic assessment is obtained through the principal investigator or sub-investigator asking each subject at each visit for any new illnesses or unexpected events.</desc>
      <group_list>
        <group group_id="E1">
          <title>High Energy Treatment Group</title>
          <description>Subjects in this group received one or two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group were offered a third optional treatment at one of these settings.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</description>
        </group>
        <group group_id="E2">
          <title>Low Energy Placebo Group</title>
          <description>Subjects in this group were offered two optional high-energy treatments subsequent to receiving the two light-energy treatments. Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low-energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high-energy treatments subsequent to receiving the two light-energy treatments.&#xD;
Syneron-Candela CO2RE Laser: This fractionated ablative laser administered energy at either a high-intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It was operated by the principal investigator, who has extensive experience with laser therapy.</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="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="7" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal Cell Carcinoma of the Skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </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>Two raters were used to rate the appearance of the scars. More raters will have been helpful.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Research Manager/Coordinator</name_or_title>
      <organization>Dermatology SLUCare Physician Group</organization>
      <phone>314 977-1794</phone>
      <email>rhonda.lebbing@health.slu.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/NCT02985151
org study id: SLU-27403
nct id: NCT02985151
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study evaluates the effect of a fractionated carbon dioxide laser on surgical scars of
      the face and neck over 12 months. Anyone with a surgical scar on the face and neck who has
      not had laser therapy may be eligible to participate. The visits occur every three months for
      up to 12 months. Subjects will be randomly assigned to receive a higher energy treatment or a
      lower energy treatment during the study. Subjects and raters will be blinded to which therapy
      level the patient receives. At each visit, the scars will be photographed and the subject
      will complete a questionnaire to rate the scar prior to treatment. Three physicians will
      evaluate the scar at each visit. One rater will evaluate the scars in person during the
      visit, while the other two raters will evaluate the scars using photographs after each visit.
      During the first three study visits, subjects will receive their assigned treatment, obtain
      post-treatment instructions, and a diary to record redness, swelling, pain, itching, or other
      skin changes after treatment. At the third study visit, subjects will have the option to
      receive additional treatments or terminate their participation in the study. The fourth visit
      for those who continue will be a treatment visit for one group and the fifth visit will be
      for data collection, with no treatment offered.
In dermatology, the use of Light Amplification by Stimulated Emission of Radiation (laser)
      has revolutionized the management of various conditions including angiomas, vitiligo,
      wrinkles, and scars. (Omi, 2014 and Chapas, 2008) Scars result from sub-optimal collagen
      production during wound healing leading to topographical irregularities. To effectively
      modify these defects, any treatment must be capable of penetrating the epidermis and
      eliciting dermal remodeling at a depth of at least 1 mm. The 10,600 nm carbon dioxide (CO2)
      laser utilizes high energy at short durations to vaporize intra- and extra-cellular water,
      resulting in tissue ablation causing a substantial thermal injury to the dermis, reducing the
      likelihood of additional scarring. The CO2 laser can stimulate collagen production and
      theoretically improve scar thickness, pliability, and texture.

      This study is a prospective, randomized double-blinded placebo-controlled trial to evaluate
      the efficacy of fractionated carbon dioxide laser in improving surgical scars on the head and
      neck over 3-5 study visits for a duration of 12.5 months. Scar assessments will be based on
      objective changes identified on pictures taken with the Canfield Vectra M3 3D Imaging System
      and subjective changes identified with the Patient and Observer Scar Assessment Scale
      (POSAS), a validated scar scale. As a secondary objective, the study will evaluate the
      tolerability of the laser, by assessing the severity and duration of known side effects of
      laser therapy such as erythema, edema, burning sensation, post-inflammatory pigment changes,
      infection, scarring, xerosis, pruritus, bronzing, and any other adverse events that arise
      following treatment. Subjects will be given a diary after each treatment to document this
      information.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a crossover study where subjects are randomized into two arms. Subjects in the sham arm are allowed to crossover at the end of their initial intervention period.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Vectra Measured Length V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
time frame: 3 months (month 0-3 for original randomized group, month 6-9 for crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
measure: In Person Blinded Observer POSAS Change V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
time frame: 3 months (month 0-3 for original randomized group, month 6-9 for crossover group)
description: Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
measure: Change in Vectra Measured Width V1 (Month 0)-V2 (Month 3) for Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
time frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.
measure: Change in Vectra Measured Surface Area V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
time frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the surface area of the scar after laser therapy.
measure: Change in Vectra Measured Length V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
time frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the length of the scar after laser therapy.
measure: Change in Vectra Measured Width V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
time frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the width of the scar after laser therapy.
measure: Change in Vectra Measured Surface Area V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
time frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
description: Utilizing the Vectra microtopographic imaging system, the study team will measure changes in the suface area of the scar after laser therapy.
measure: In-person Blinded Observer Change POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
time frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
description: Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
measure: Change in Blinded Photo Observer Score POSAS V1 (Month 0)-V2 (Month 3) for the Original Group; Visit 3 (Month 6) to Visit 4 (Month 9) for Crossover Group
time frame: 3 months (months 0-3 for the original randomized group, months 6-9 for the crossover group)
description: Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by the blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
measure: Change in Blinded Photo Observer Score on POSAS V1 (Month 0)-V3 (Month 6) for the Original Group; Visit 3 (Month 6) to Visit 5 (Month 12) for Crossover Group
time frame: 6 months (months 0-6 for the original randomized group, months 6-12 for the crossover group)
description: Utilizing the Patient and Observer Scar Assessment Scale (POSAS) (a scar assessment scale), the study will evaluate features of color change, thickness, width, the texture of the scar, pain associated with the scar, and itching associated with the scar by blinded clinical evaluators. Scale is scored from 1-10 with higher scores indicating a worse scar. A change in the total score is being reported.
measure: Tolerability Associated With the Laser Treatment at V1 (Month 0) and V2 (Month 3) for the Original Group; Visit 3 (Month 6) and Visit 4 (Month 9) for Crossover Group
time frame: V1 (month 0) and V2 (month 3) for the original group; visit 3 (month 6) and visit 4 (month 9) for crossover group
description: Participants will be given a diary to record the severity and duration of symptoms for the day of treatment and then daily for seven days after each laser treatment: redness, scaling/flaking, pustules, swelling, pain, itching, burning, color changes (darkening and/or lightning), infection, and any other adverse events that arise following treatment. Subjects score each of the symptom severity on a scale of 0-4 (0=none, 1= mild, 2= moderate, 3= intense, 4= intolerable). The average weekly score for each group is reported below.
arm group label: High Energy Treatment Group
arm group type: Active Comparator
description: Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at either the Mid mode or the Deep mode of the laser at visits three months apart. Thereafter, individuals in this group will be offered a third optional treatment at one of these settings.
arm group label: Low Energy Placebo Group
arm group type: Placebo Comparator
description: Subjects in this group will receive at least two Syneron-Candela CO2RE laser treatments set at the Light mode of the laser at visits three months apart. The Light mode is a low energy setting that superficially cleanses the skin, and would not affect the scar, which is deeper in the skin. Individuals in this group will be offered two optional high energy treatments subsequent to receiving the two light energy treatments.
intervention type: Device
intervention name: Syneron-Candela CO2RE Laser
description: This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.
arm group label: High Energy Treatment Group
arm group label: Low Energy Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ramona Behshad, MD
role: Principal Investigator
affiliation: Saint Louis University, Department of Dermatology
facility: 
country: United States
citation: Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.
PMID: 24771971
citation: Bodendorf MO, Grunewald S, Wetzig T, Simon JC, Paasch U. Fractional laser skin therapy. J Dtsch Dermatol Ges. 2009 Apr;7(4):301-8. doi: 10.1111/j.1610-0387.2008.06845.x. Epub 2008 Aug 28. English, German.
PMID: 18761608
citation: Chapas AM, Brightman L, Sukal S, Hale E, Daniel D, Bernstein LJ, Geronemus RG. Successful treatment of acneiform scarring with CO2 ablative fractional resurfacing. Lasers Surg Med. 2008 Aug;40(6):381-6. doi: 10.1002/lsm.20659.
PMID: 18649382
citation: Majid I, Imran S. Fractional CO2 Laser Resurfacing as Monotherapy in the Treatment of Atrophic Facial Acne Scars. J Cutan Aesthet Surg. 2014 Apr;7(2):87-92. doi: 10.4103/0974-2077.138326.
PMID: 25136208
citation: van der Wal MB, Tuinebreijer WE, Bloemen MC, Verhaegen PD, Middelkoop E, van Zuijlen PP. Rasch analysis of the Patient and Observer Scar Assessment Scale (POSAS) in burn scars. Qual Life Res. 2012 Feb;21(1):13-23. doi: 10.1007/s11136-011-9924-5. Epub 2011 May 20.
PMID: 21598065
citation: Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
PMID: 15216537
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Ramona Behshad, MD
investigator title: Associate Professor, Department of Dermatology
mesh term: Cicatrix
sharing ipd: Yes
ipd description: De-identified participant data may be accessed after publication of the results in a medical journal.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Two raters were used to rate the appearance of the scars. More raters will have been helpful.
point of contact: 