<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/NCT03795116</url>
  </required_header>
  <id_info>
    <org_study_id>1304108</org_study_id>
    <nct_id>NCT03795116</nct_id>
  </id_info>
  <brief_title>Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention</brief_title>
  <official_title>Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Downstate Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Downstate Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skin scarring (fibrosis) is a common complication in the wound healing process and remains a&#xD;
      therapeutic challenge. Scar formation often occurs following injury to the skin such as&#xD;
      surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of&#xD;
      visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on&#xD;
      laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen&#xD;
      post-surgical skin fibrosis clinically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skin fibrosis is a significant global health problem that has a profoundly negative impact on&#xD;
      quality of life. Characterized by excessive fibroblast proliferation and collagen deposition,&#xD;
      skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic&#xD;
      scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases.&#xD;
      Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of&#xD;
      developing novel approaches to treat and prevent skin fibrosis.&#xD;
&#xD;
      In vitro data show that LED-RL can modulate key cellular and molecular processes involved in&#xD;
      skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and&#xD;
      tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The&#xD;
      administration of LED-RL phototherapy in the early postoperative period may optimize wound&#xD;
      healing and prevent excessive scarring. The results from this study may change the current&#xD;
      treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe,&#xD;
      non-invasive, cost-effective, portable, at-home therapy for scars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">October 26, 2020</completion_date>
  <primary_completion_date type="Actual">October 26, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>This is a single-blind study. Participants and clinicians involved in subjective efficacy assessments will be blind to the study intervention (LED-RL phototherapy versus mock therapy). The principal investigator, along with the research coordinator who administers the LED-RL phototherapy, will be aware of each participant's treatment assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observer Scar Assessment Scale</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates &quot;normal skin&quot; and 10 corresponds to the &quot;worst possible scar,&quot; for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermal Collagen Concentration</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermal Water Concentration</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3D Imaging Analysis: Pigmentation of Scar Tissue</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3D Imaging Analysis: Vascularity of Scar Tissue</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3D Imaging Analysis: Volume of Elevation of Scar Tissue</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological Analysis: Collagen Content of Scar Tissue (Optional)</measure>
    <time_frame>Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).</time_frame>
    <description>The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing Adverse Events in Each Treatment Group</measure>
    <time_frame>From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).</time_frame>
    <description>Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Scar Assessment Scale</measure>
    <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
    <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Fibrosis</condition>
  <condition>Skin Scarring</condition>
  <condition>Skin Wound</condition>
  <condition>Hypertrophic Scar</condition>
  <condition>Scar</condition>
  <condition>Keloid</condition>
  <arm_group>
    <arm_group_label>LED-RL phototherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mock irradiation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LED-RL phototherapy</intervention_name>
    <description>The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
    <arm_group_label>LED-RL phototherapy</arm_group_label>
    <other_name>Omnilux handheld LED system (GlobalMed Technologies, Glen Ellen, CA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mock irradiation</intervention_name>
    <description>The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
    <arm_group_label>Mock irradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of written informed consent for all study procedures&#xD;
&#xD;
          -  Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          -  Suitable candidate for elective mini-facelift surgery&#xD;
&#xD;
          -  Pass a screening photosensitivity test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of any photosensitizing medications&#xD;
&#xD;
          -  Light-sensitive conditions&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Systemic lupus erythematosus&#xD;
&#xD;
          -  Current tobacco use&#xD;
&#xD;
          -  History of bleeding or coagulation disorder&#xD;
&#xD;
          -  Lax skin associated with genetic disorders&#xD;
&#xD;
          -  Open wounds on the face or neck&#xD;
&#xD;
          -  Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the&#xD;
             periauricular skin&#xD;
&#xD;
          -  History of surgery or procedure involving or affecting the periauricular skin within&#xD;
             the past 6 months (e.g., prior facelift, fillers, laser therapy)&#xD;
&#xD;
          -  Tattoos that cover the proposed treatment sites on the periauricular skin&#xD;
&#xD;
          -  Any other medical condition(s) that could be compromised by exposure to the proposed&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SUNY Downstate Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>August 11, 2021</results_first_submitted>
  <results_first_submitted_qc>May 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2022</results_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York - Downstate Medical Center</investigator_affiliation>
    <investigator_full_name>Jared Jagdeo, MD, MS</investigator_full_name>
    <investigator_title>Associate Professor of Dermatology</investigator_title>
  </responsible_party>
  <keyword>Light emitting diode</keyword>
  <keyword>Light emitting diode-red light</keyword>
  <keyword>Visible red light</keyword>
  <keyword>Skin fibrosis</keyword>
  <keyword>Wound healing</keyword>
  <keyword>Scarring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Cicatrix</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>July 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03795116/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>30 participants were included in the study. This was a split-face study in which each patient received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LED-RL Phototherapy Group 1</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
        </group>
        <group group_id="P2">
          <title>Mock Irradiation Group 1</title>
          <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
        </group>
        <group group_id="P3">
          <title>LED-RL Phototherapy Group 2</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
        </group>
        <group group_id="P4">
          <title>Mock Irradiation Group 2</title>
          <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
        </group>
        <group group_id="P5">
          <title>LED-RL Phototherapy Group 3</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
        </group>
        <group group_id="P6">
          <title>Mock Irradiation Group 3</title>
          <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>30 participants were enrolled and included in the split-face study (i.e., began the study protocol).</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants Group 1</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Group 1 participants received Low dose LED-RL (160 J/cm2) for 30 minutes on one incision site and mock phototherapy for 30 minutes on the other incision site.</description>
        </group>
        <group group_id="B2">
          <title>All Participants Group 2</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Group 2 participants received medium dose LED-RL (320 J/cm2) for 60 minutes on one incision site and mock phototherapy for 60 minutes on the other incision site.</description>
        </group>
        <group group_id="B3">
          <title>All Participants Group 3</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Group 3 participants received high dose LED-RL (480 J/cm2) for 90 minutes on one incision site and mock phototherapy for 90 minutes on the other incision site.</description>
        </group>
        <group group_id="B4">
          <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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="30"/>
          </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="53.7" spread="8.2"/>
                    <measurement group_id="B2" value="52.4" spread="7.2"/>
                    <measurement group_id="B3" value="56.3" spread="7.4"/>
                    <measurement group_id="B4" value="54.1" spread="7.5"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White non-hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Two or more races</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline</title>
        <description>The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).</description>
        <time_frame>1 month, 3 months, 6 months</time_frame>
        <population>Collected data were not considered valid due to an equipment malfunction.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline</title>
          <description>The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).</description>
          <population>Collected data were not considered valid due to an equipment malfunction.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline</title>
        <description>The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline</title>
          <description>The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).</description>
          <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
          <units>Newton</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Incision Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Incision Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".08" lower_limit=".04" upper_limit=".14"/>
                    <measurement group_id="O2" value=".05" lower_limit=".02" upper_limit=".08"/>
                    <measurement group_id="O3" value=".09" lower_limit=".03" upper_limit=".13"/>
                    <measurement group_id="O4" value=".06" lower_limit=".04" upper_limit=".08"/>
                    <measurement group_id="O5" value=".06" lower_limit=".04" upper_limit=".07"/>
                    <measurement group_id="O6" value=".07" lower_limit=".02" upper_limit=".08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".05" lower_limit=".04" upper_limit=".08"/>
                    <measurement group_id="O2" value=".04" lower_limit=".03" upper_limit=".08"/>
                    <measurement group_id="O3" value=".06" lower_limit=".04" upper_limit=".08"/>
                    <measurement group_id="O4" value=".05" lower_limit=".03" upper_limit=".12"/>
                    <measurement group_id="O5" value=".05" lower_limit=".03" upper_limit=".08"/>
                    <measurement group_id="O6" value=".04" lower_limit=".02" upper_limit=".04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".03" lower_limit=".03" upper_limit=".06"/>
                    <measurement group_id="O2" value=".04" lower_limit=".02" upper_limit=".05"/>
                    <measurement group_id="O3" value=".04" lower_limit=".03" upper_limit=".07"/>
                    <measurement group_id="O4" value=".04" lower_limit=".04" upper_limit=".07"/>
                    <measurement group_id="O5" value=".05" lower_limit=".04" upper_limit=".06"/>
                    <measurement group_id="O6" value=".06" lower_limit=".04" upper_limit=".08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".03" lower_limit=".02" upper_limit=".03"/>
                    <measurement group_id="O2" value=".03" lower_limit=".02" upper_limit=".03"/>
                    <measurement group_id="O3" value=".02" lower_limit=".02" upper_limit=".03"/>
                    <measurement group_id="O4" value=".03" lower_limit=".03" upper_limit=".03"/>
                    <measurement group_id="O5" value=".03" lower_limit=".02" upper_limit=".03"/>
                    <measurement group_id="O6" value=".02" lower_limit=".02" upper_limit=".03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Observer Scar Assessment Scale</title>
        <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Observer Scar Assessment Scale</title>
          <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
          <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Incision Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Incision Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" lower_limit="14.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="16.5" lower_limit="15.0" upper_limit="21.0"/>
                    <measurement group_id="O3" value="19.0" lower_limit="16.0" upper_limit="21.0"/>
                    <measurement group_id="O4" value="14.0" lower_limit="13.0" upper_limit="17.0"/>
                    <measurement group_id="O5" value="18.0" lower_limit="16.0" upper_limit="19.0"/>
                    <measurement group_id="O6" value="16.5" lower_limit="15.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0" lower_limit="15.0" upper_limit="18.0"/>
                    <measurement group_id="O2" value="17.0" lower_limit="14.0" upper_limit="19.0"/>
                    <measurement group_id="O3" value="13.0" lower_limit="11.0" upper_limit="16.0"/>
                    <measurement group_id="O4" value="17.5" lower_limit="11.0" upper_limit="19.0"/>
                    <measurement group_id="O5" value="19.0" lower_limit="17.0" upper_limit="21.0"/>
                    <measurement group_id="O6" value="13.0" lower_limit="12.0" upper_limit="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="11.5" upper_limit="17.0"/>
                    <measurement group_id="O2" value="15.0" lower_limit="14.0" upper_limit="16.0"/>
                    <measurement group_id="O3" value="12.0" lower_limit="11.0" upper_limit="18.0"/>
                    <measurement group_id="O4" value="14.0" lower_limit="9.0" upper_limit="18.0"/>
                    <measurement group_id="O5" value="15.0" lower_limit="12.0" upper_limit="19.0"/>
                    <measurement group_id="O6" value="13.0" lower_limit="12.0" upper_limit="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.0" upper_limit="18.0"/>
                    <measurement group_id="O2" value="12.5" lower_limit="11.0" upper_limit="14.0"/>
                    <measurement group_id="O3" value="8.0" lower_limit="8.0" upper_limit="20.0"/>
                    <measurement group_id="O4" value="14.0" lower_limit="12.0" upper_limit="16.0"/>
                    <measurement group_id="O5" value="13.0" lower_limit="10.0" upper_limit="15.0"/>
                    <measurement group_id="O6" value="12.0" lower_limit="8.0" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars</title>
        <description>The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates &quot;normal skin&quot; and 10 corresponds to the &quot;worst possible scar,&quot; for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>Data were not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars</title>
          <description>The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates &quot;normal skin&quot; and 10 corresponds to the &quot;worst possible scar,&quot; for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.</description>
          <population>Data were not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dermal Collagen Concentration</title>
        <description>A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Dermal Collagen Concentration</title>
          <description>A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.</description>
          <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
          <units>arbitrary units</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Incision Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Incision Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7" lower_limit="41.0" upper_limit="59.5"/>
                    <measurement group_id="O2" value="52.0" lower_limit="37.0" upper_limit="62.6"/>
                    <measurement group_id="O3" value="51.0" lower_limit="34.0" upper_limit="59.0"/>
                    <measurement group_id="O4" value="50.5" lower_limit="42.0" upper_limit="62.0"/>
                    <measurement group_id="O5" value="47.7" lower_limit="39.3" upper_limit="62.0"/>
                    <measurement group_id="O6" value="52.5" lower_limit="46.0" upper_limit="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.3" lower_limit="50.0" upper_limit="62.0"/>
                    <measurement group_id="O2" value="47.0" lower_limit="29.3" upper_limit="56.3"/>
                    <measurement group_id="O3" value="50.7" lower_limit="44.7" upper_limit="58.0"/>
                    <measurement group_id="O4" value="55.2" lower_limit="43.7" upper_limit="60.0"/>
                    <measurement group_id="O5" value="52.7" lower_limit="42.3" upper_limit="60.7"/>
                    <measurement group_id="O6" value="57.0" lower_limit="48.3" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" lower_limit="47.8" upper_limit="60.3"/>
                    <measurement group_id="O2" value="57.4" lower_limit="55.5" upper_limit="61.5"/>
                    <measurement group_id="O3" value="58.3" lower_limit="55.0" upper_limit="60.7"/>
                    <measurement group_id="O4" value="57.3" lower_limit="54.7" upper_limit="58.0"/>
                    <measurement group_id="O5" value="58.7" lower_limit="48.0" upper_limit="59.6"/>
                    <measurement group_id="O6" value="58.7" lower_limit="55.6" upper_limit="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="55.3" upper_limit="58.7"/>
                    <measurement group_id="O2" value="56.5" lower_limit="53.0" upper_limit="60.3"/>
                    <measurement group_id="O3" value="60.0" lower_limit="56.0" upper_limit="61.7"/>
                    <measurement group_id="O4" value="61.0" lower_limit="54.7" upper_limit="61.3"/>
                    <measurement group_id="O5" value="56.7" lower_limit="50.3" upper_limit="57.0"/>
                    <measurement group_id="O6" value="59.3" lower_limit="56.7" upper_limit="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dermal Water Concentration</title>
        <description>A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Dermal Water Concentration</title>
          <description>A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.</description>
          <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
          <units>percentage</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Incision Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Incision Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0" lower_limit="60.0" upper_limit="64.3"/>
                    <measurement group_id="O2" value="65.3" lower_limit="62.3" upper_limit="66.0"/>
                    <measurement group_id="O3" value="60.7" lower_limit="58.7" upper_limit="62.0"/>
                    <measurement group_id="O4" value="62.7" lower_limit="60.0" upper_limit="66.0"/>
                    <measurement group_id="O5" value="63.2" lower_limit="62.0" upper_limit="67.7"/>
                    <measurement group_id="O6" value="66.2" lower_limit="63.0" upper_limit="68.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.0" lower_limit="62.0" upper_limit="65.0"/>
                    <measurement group_id="O2" value="62.3" lower_limit="61.3" upper_limit="63.3"/>
                    <measurement group_id="O3" value="60.2" lower_limit="58.3" upper_limit="61.7"/>
                    <measurement group_id="O4" value="62.3" lower_limit="58.3" upper_limit="63.3"/>
                    <measurement group_id="O5" value="60.6" lower_limit="58.7" upper_limit="62.7"/>
                    <measurement group_id="O6" value="64.0" lower_limit="60.0" upper_limit="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.0" lower_limit="59.7" upper_limit="67.8"/>
                    <measurement group_id="O2" value="61.4" lower_limit="59.0" upper_limit="67.3"/>
                    <measurement group_id="O3" value="63.0" lower_limit="59.7" upper_limit="66.3"/>
                    <measurement group_id="O4" value="60.7" lower_limit="59.3" upper_limit="62.3"/>
                    <measurement group_id="O5" value="61.7" lower_limit="60.6" upper_limit="63.3"/>
                    <measurement group_id="O6" value="62.0" lower_limit="57.0" upper_limit="67.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" lower_limit="59.0" upper_limit="64.3"/>
                    <measurement group_id="O2" value="61.2" lower_limit="59.7" upper_limit="64.0"/>
                    <measurement group_id="O3" value="63.7" lower_limit="62.3" upper_limit="68.3"/>
                    <measurement group_id="O4" value="63.0" lower_limit="62.7" upper_limit="64.7"/>
                    <measurement group_id="O5" value="62.0" lower_limit="61.3" upper_limit="62.3"/>
                    <measurement group_id="O6" value="64.0" lower_limit="61.3" upper_limit="64.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3D Imaging Analysis: Pigmentation of Scar Tissue</title>
        <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>Data were not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>3D Imaging Analysis: Pigmentation of Scar Tissue</title>
          <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.</description>
          <population>Data were not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3D Imaging Analysis: Vascularity of Scar Tissue</title>
        <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>Data were not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>3D Imaging Analysis: Vascularity of Scar Tissue</title>
          <description>A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.</description>
          <population>Data were not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>3D Imaging Analysis: Volume of Elevation of Scar Tissue</title>
        <description>A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>Data were not collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>3D Imaging Analysis: Volume of Elevation of Scar Tissue</title>
          <description>A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.</description>
          <population>Data were not collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Histological Analysis: Collagen Content of Scar Tissue (Optional)</title>
        <description>The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.</description>
        <time_frame>Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).</time_frame>
        <population>Biopsy was optional. This outcome measure was not performed for any subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.</description>
          </group>
        </group_list>
        <measure>
          <title>Histological Analysis: Collagen Content of Scar Tissue (Optional)</title>
          <description>The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.</description>
          <population>Biopsy was optional. This outcome measure was not performed for any subjects.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing Adverse Events in Each Treatment Group</title>
        <description>Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.</description>
        <time_frame>From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).</time_frame>
        <population>This was a split-face study including 30 participants. Each participant received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes.</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes.</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing Adverse Events in Each Treatment Group</title>
          <description>Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.</description>
          <population>This was a split-face study including 30 participants. Each participant received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>localized bulla</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>localized facial swelling</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>no adverse events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Scar Assessment Scale</title>
        <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
        <time_frame>Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).</time_frame>
        <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>LED-RL Phototherapy Group 1</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes</description>
          </group>
          <group group_id="O2">
            <title>Mock Irradiation Group 1</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
          </group>
          <group group_id="O3">
            <title>LED-RL Phototherapy Group 2</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes</description>
          </group>
          <group group_id="O4">
            <title>Mock Irradiation Group 2</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
          </group>
          <group group_id="O5">
            <title>LED-RL Phototherapy Group 3</title>
            <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes</description>
          </group>
          <group group_id="O6">
            <title>Mock Irradiation Group 3</title>
            <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Scar Assessment Scale</title>
          <description>The scale consists of six items rated from 1 to 10, where 1 is &quot;normal skin&quot; and 10 is the &quot;worst imaginable scar&quot;. The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).</description>
          <population>In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Incision Sites</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Incision Sites</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0" lower_limit="27.0" upper_limit="42.0"/>
                    <measurement group_id="O2" value="37.0" lower_limit="24.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="32.0" lower_limit="23.0" upper_limit="34.0"/>
                    <measurement group_id="O4" value="30.5" lower_limit="27.0" upper_limit="32.0"/>
                    <measurement group_id="O5" value="26.5" lower_limit="21.0" upper_limit="33.0"/>
                    <measurement group_id="O6" value="28.5" lower_limit="24.0" upper_limit="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="21.0" upper_limit="34.0"/>
                    <measurement group_id="O2" value="25.0" lower_limit="19.0" upper_limit="34.0"/>
                    <measurement group_id="O3" value="24.0" lower_limit="19.0" upper_limit="29.0"/>
                    <measurement group_id="O4" value="23.5" lower_limit="18.0" upper_limit="30.0"/>
                    <measurement group_id="O5" value="17.0" lower_limit="13.0" upper_limit="37.0"/>
                    <measurement group_id="O6" value="26.0" lower_limit="13.0" upper_limit="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="12.0" upper_limit="18.0"/>
                    <measurement group_id="O2" value="15.0" lower_limit="12.0" upper_limit="25.5"/>
                    <measurement group_id="O3" value="18.0" lower_limit="17.0" upper_limit="26.0"/>
                    <measurement group_id="O4" value="21.0" lower_limit="18.0" upper_limit="26.0"/>
                    <measurement group_id="O5" value="17.5" lower_limit="14.0" upper_limit="32.0"/>
                    <measurement group_id="O6" value="20.0" lower_limit="12.0" upper_limit="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Incision Sites</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="7.0" upper_limit="17.0"/>
                    <measurement group_id="O2" value="10.5" lower_limit="10.0" upper_limit="12.0"/>
                    <measurement group_id="O3" value="23.0" lower_limit="12.0" upper_limit="28.0"/>
                    <measurement group_id="O4" value="18.0" lower_limit="16.0" upper_limit="24.0"/>
                    <measurement group_id="O5" value="13.0" lower_limit="10.0" upper_limit="25.0"/>
                    <measurement group_id="O6" value="17.0" lower_limit="11.0" upper_limit="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LED-RL Phototherapy Group 1</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes.</description>
        </group>
        <group group_id="E2">
          <title>Mock Irradiation Group 1</title>
          <description>30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 1: Received mock phototherapy for 30 minutes.</description>
        </group>
        <group group_id="E3">
          <title>LED-RL Phototherapy Group 2</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes.</description>
        </group>
        <group group_id="E4">
          <title>Mock Irradiation Group 2</title>
          <description>30 subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 2: Received mock phototherapy for 60 minutes.</description>
        </group>
        <group group_id="E5">
          <title>LED-RL Phototherapy Group 3</title>
          <description>30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes.</description>
        </group>
        <group group_id="E6">
          <title>Mock Irradiation Group 3</title>
          <description>Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.&#xD;
Mock irradiation group 3: Received mock phototherapy for 90 minutes.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </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="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Localized Bulla</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Localized Facial Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </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>
    <point_of_contact>
      <name_or_title>Jared Jagdeo MD, MS</name_or_title>
      <organization>SUNY Downstate Health Sciences University</organization>
      <phone>347-466-9263</phone>
      <email>jared.jagdeo@downstate.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/NCT03795116
org study id: 1304108
nct id: NCT03795116
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Skin scarring (fibrosis) is a common complication in the wound healing process and remains a
      therapeutic challenge. Scar formation often occurs following injury to the skin such as
      surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of
      visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on
      laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen
      post-surgical skin fibrosis clinically.
Skin fibrosis is a significant global health problem that has a profoundly negative impact on
      quality of life. Characterized by excessive fibroblast proliferation and collagen deposition,
      skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic
      scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases.
      Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of
      developing novel approaches to treat and prevent skin fibrosis.

      In vitro data show that LED-RL can modulate key cellular and molecular processes involved in
      skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and
      tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The
      administration of LED-RL phototherapy in the early postoperative period may optimize wound
      healing and prevent excessive scarring. The results from this study may change the current
      treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe,
      non-invasive, cost-effective, portable, at-home therapy for scars.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: This is a single-blind study. Participants and clinicians involved in subjective efficacy assessments will be blind to the study intervention (LED-RL phototherapy versus mock therapy). The principal investigator, along with the research coordinator who administers the LED-RL phototherapy, will be aware of each participant's treatment assignment.
measure: Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline
time frame: 1 month, 3 months, 6 months
description: The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).
measure: Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).
measure: Observer Scar Assessment Scale
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).
measure: Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates "normal skin" and 10 corresponds to the "worst possible scar," for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.
measure: Dermal Collagen Concentration
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.
measure: Dermal Water Concentration
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.
measure: 3D Imaging Analysis: Pigmentation of Scar Tissue
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.
measure: 3D Imaging Analysis: Vascularity of Scar Tissue
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.
measure: 3D Imaging Analysis: Volume of Elevation of Scar Tissue
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.
measure: Histological Analysis: Collagen Content of Scar Tissue (Optional)
time frame: Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).
description: The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.
measure: Number of Participants Experiencing Adverse Events in Each Treatment Group
time frame: From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).
description: Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.
measure: Patient Scar Assessment Scale
time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
description: The scale consists of six items rated from 1 to 10, where 1 is "normal skin" and 10 is the "worst imaginable scar". The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).
arm group label: LED-RL phototherapy
arm group type: Experimental
description: Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
arm group label: Mock irradiation
arm group type: Sham Comparator
description: Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
intervention type: Device
intervention name: LED-RL phototherapy
description: The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
arm group label: LED-RL phototherapy
other name: Omnilux handheld LED system (GlobalMed Technologies, Glen Ellen, CA)
intervention type: Device
intervention name: Mock irradiation
description: The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
arm group label: Mock irradiation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York - Downstate Medical Center
investigator full name: Jared Jagdeo, MD, MS
investigator title: Associate Professor of Dermatology
mesh term: Fibrosis
mesh term: Cicatrix
mesh term: Cicatrix, Hypertrophic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 