<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/NCT01702259</url>
  </required_header>
  <id_info>
    <org_study_id>EMCTE002</org_study_id>
    <nct_id>NCT01702259</nct_id>
  </id_info>
  <brief_title>Study of the Effect of Low Level Laser Light Therapy on Reducing the Appearance of Cellulite in the Thighs and Buttocks.</brief_title>
  <official_title>A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Reducing the Appearance of Cellulite Clinical Study Protocol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erchonia Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erchonia Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the application of green diode low level&#xD;
      laser light therapy is effective in reducing the appearance of cellulite in the thighs and&#xD;
      buttocks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cellulite is a common term used to describe superficial pockets of trapped fat, which causes&#xD;
      uneven dimpling or &quot;orange peel&quot; skin. It appears in 90% of post-adolescent women. In&#xD;
      advanced stages of cellulite, heaviness and pain may occur.&#xD;
&#xD;
      Currently available treatments for cellulite have minimal to no demonstrable effect and some&#xD;
      involve risky invasive procedures. Therefore, the potential advantages of the application of&#xD;
      low level laser light therapy to reduce the appearance of cellulite over current treatment&#xD;
      options include a risk free procedure that is non-invasive and pain free. Since low level&#xD;
      laser light within the green spectrum has been proven to increase the synthesis of collagen,&#xD;
      it is believed that its application may serve to decrease the appearance of cellulite by&#xD;
      tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of&#xD;
      the connective tissue responsible for the formation of cellulite.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects That Met the Individual Success Criteria</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bilateral Upper Thigh Circumference Measurement</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>Body weight is measured in pounds (lbs) using a digital scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.</measure>
    <time_frame>Baseline and 2 weeks</time_frame>
    <description>The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Study Outcome</measure>
    <time_frame>2 Weeks</time_frame>
    <description>At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:&#xD;
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied&#xD;
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Cellulite</condition>
  <arm_group>
    <arm_group_label>Erchonia Scanner device (GLS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo device</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Inactive Erchonia GLS device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Erchonia Scanner device (GLS)</intervention_name>
    <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.</description>
    <arm_group_label>Erchonia Scanner device (GLS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo device</intervention_name>
    <description>Inactive Erchonia GLS.</description>
    <arm_group_label>Placebo device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Areas for which cellulite appearance reduction is being sought are the bilateral&#xD;
             thighs and buttocks&#xD;
&#xD;
          -  Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for&#xD;
             each treatment area&#xD;
&#xD;
          -  PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status&#xD;
             Classification System&#xD;
&#xD;
          -  Willing and able to abstain from partaking in any treatment other than the study&#xD;
             procedure to promote cellulite appearance reduction/body contouring/weight loss during&#xD;
             the study&#xD;
&#xD;
          -  Willing and able to maintain regular diet and exercise regimen without effecting&#xD;
             significant change in either direction during the study&#xD;
&#xD;
          -  Willing and able to maintain regular medication schedule, as is medically feasible,&#xD;
             during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for&#xD;
             either one or both thighs/buttocks&#xD;
&#xD;
          -  P3 or P4 or P5 or P6 on the ASA Physical Status Classification System&#xD;
&#xD;
          -  Weight fluctuation greater than 10 pounds in the prior month&#xD;
&#xD;
          -  Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6&#xD;
             months&#xD;
&#xD;
          -  Prior surgical intervention to the treatment areas, for any reason&#xD;
&#xD;
          -  Medical, physical or other contraindications for cellulite reduction/body&#xD;
             contouring/weight loss&#xD;
&#xD;
          -  Current use of medication(s) known to affect weight levels and/or cause bloating or&#xD;
             swelling and for which abstinence during the study is not safe or medically prudent&#xD;
&#xD;
          -  Any medical condition known to affect weight levels, cause bloating or swelling&#xD;
&#xD;
          -  Diagnosis of, and/or taking medication for, irritable bowel syndrome&#xD;
&#xD;
          -  Active infection, wound or other external trauma to the study treatment areas&#xD;
&#xD;
          -  Dermatitis or significant scarring in the study treatment areas&#xD;
&#xD;
          -  Medical, physical, or other contraindications for, or known sensitivity to, light&#xD;
             therapy&#xD;
&#xD;
          -  Diabetes dependent on insulin or oral hypoglycemic medications&#xD;
&#xD;
          -  Known cardiovascular disease&#xD;
&#xD;
          -  Cardiac surgeries&#xD;
&#xD;
          -  History of deep venous thrombosis, arterial disease of the legs&#xD;
&#xD;
          -  Pregnant, breast feeding, or planning pregnancy prior to study end&#xD;
&#xD;
          -  Serious mental health illness or psychiatric hospitalization in past 2 years&#xD;
&#xD;
          -  Developmental disability or cognitive impairment that would impact study participation&#xD;
&#xD;
          -  Involved in litigation/receiving disability benefits related to the parameters of the&#xD;
             study&#xD;
&#xD;
          -  Participation in research in the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory C Roche, D.O.</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Robert F Jackson, M.D.</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Surgeon's Inc.</name>
      <address>
        <city>Marion</city>
        <state>Indiana</state>
        <zip>46952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bloomfield Laser and Cosmetic Surgery Center</name>
      <address>
        <city>Bloomfield Hills</city>
        <state>Michigan</state>
        <zip>48302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>July 9, 2015</results_first_submitted>
  <results_first_submitted_qc>November 8, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 11, 2015</results_first_posted>
  <last_update_submitted>November 8, 2015</last_update_submitted>
  <last_update_submitted_qc>November 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulite</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Erchonia Scanner Device (GLS)</title>
          <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Device</title>
          <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Erchonia Scanner Device (GLS)</title>
          <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Device</title>
          <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="34"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="68"/>
          </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="39.87" spread="10.08"/>
                    <measurement group_id="B2" value="39.94" spread="10.72"/>
                    <measurement group_id="B3" value="39.91" spread="10.36"/>
                  </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="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="68"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stage on the Nurnberger-Muller Scale (NMS)</title>
          <description>The Nurnberger-Muller Scale (NMS) is a four-stage scale to classify stage or degree of cellulite. Stage II is defined as dimpling appearing spontaneously when standing but not when lying down. Orange peel appearance of the skin is evident to the naked eye without need for manipulation. Stage III is defined as dimpling spontaneously present with standing and lying down, evident to the naked eye without manipulation. Orange peel skin surface appearance with raised areas and nodules. NMS is assessed for both legs of each participant, and the worse of the stages is reported.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Stage II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Circumference measurement</title>
          <description>Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure at standardized measurement points. Results are reported as combined bilateral (right+left thigh) circumference measurements.</description>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.09" spread="3.65"/>
                    <measurement group_id="B2" value="46.05" spread="4.66"/>
                    <measurement group_id="B3" value="46.55" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Measured as kilograms per meter squared (kg/m2)</description>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.42" spread="2.84"/>
                    <measurement group_id="B2" value="24.98" spread="2.77"/>
                    <measurement group_id="B3" value="25.22" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent Total Body Surface Area (TBSA)</title>
          <description>The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.</description>
          <units>percentage of TBSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.52" spread="6.06"/>
                    <measurement group_id="B2" value="14.38" spread="7.01"/>
                    <measurement group_id="B3" value="14.87" spread="6.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects That Met the Individual Success Criteria</title>
        <description>The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia Scanner Device (GLS)</title>
            <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Device</title>
            <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Met the Individual Success Criteria</title>
          <description>The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bilateral Upper Thigh Circumference Measurement</title>
        <description>Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia Scanner Device (GLS)</title>
            <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Device</title>
            <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Bilateral Upper Thigh Circumference Measurement</title>
          <description>Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.</description>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="1.01"/>
                    <measurement group_id="O2" value="-0.39" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Body Weight</title>
        <description>Body weight is measured in pounds (lbs) using a digital scale.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia Scanner Device (GLS)</title>
            <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Device</title>
            <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Body weight is measured in pounds (lbs) using a digital scale.</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="1.62"/>
                    <measurement group_id="O2" value="-0.31" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.</title>
        <description>The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.</description>
        <time_frame>Baseline and 2 weeks</time_frame>
        <population>The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Erchonia Scanner Device (GLS)</title>
            <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Device</title>
            <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.</title>
          <description>The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.</description>
          <population>The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.</population>
          <units>percentage of TBSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.89" spread="1.45"/>
                    <measurement group_id="O2" value="-0.66" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Study Outcome</title>
        <description>At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:&#xD;
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied&#xD;
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.</description>
        <time_frame>2 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia Scanner Device (GLS)</title>
            <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Device</title>
            <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Study Outcome</title>
          <description>At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:&#xD;
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied&#xD;
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Erchonia Scanner Device (GLS)</title>
          <description>The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.&#xD;
Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Device</title>
          <description>Inactive Erchonia GLS device&#xD;
Placebo device: Inactive Erchonia GLS.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </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>Dr. Robert F. Jackson</name_or_title>
      <organization>Surgeon's Inc.</organization>
      <phone>765-662-8303</phone>
      <email>rjlipodr@comteck.com</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/NCT01702259
org study id: EMCTE002
nct id: NCT01702259
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether the application of green diode low level
      laser light therapy is effective in reducing the appearance of cellulite in the thighs and
      buttocks.
Cellulite is a common term used to describe superficial pockets of trapped fat, which causes
      uneven dimpling or "orange peel" skin. It appears in 90% of post-adolescent women. In
      advanced stages of cellulite, heaviness and pain may occur.

      Currently available treatments for cellulite have minimal to no demonstrable effect and some
      involve risky invasive procedures. Therefore, the potential advantages of the application of
      low level laser light therapy to reduce the appearance of cellulite over current treatment
      options include a risk free procedure that is non-invasive and pain free. Since low level
      laser light within the green spectrum has been proven to increase the synthesis of collagen,
      it is believed that its application may serve to decrease the appearance of cellulite by
      tightening the skin. Moreover, newly synthesized collagen may alter the irregular pattern of
      the connective tissue responsible for the formation of cellulite.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Subjects That Met the Individual Success Criteria
time frame: Baseline and 2 weeks
description: The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.
measure: Bilateral Upper Thigh Circumference Measurement
time frame: Baseline and 2 weeks
description: Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.
measure: Change in Body Weight
time frame: Baseline and 2 weeks
description: Body weight is measured in pounds (lbs) using a digital scale.
measure: Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.
time frame: Baseline and 2 weeks
description: The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.
measure: Patient Satisfaction With Study Outcome
time frame: 2 Weeks
description: At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:
Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied
Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome.
arm group label: Erchonia Scanner device (GLS)
arm group type: Experimental
description: The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
arm group label: Placebo device
arm group type: Sham Comparator
description: Inactive Erchonia GLS device
intervention type: Device
intervention name: Erchonia Scanner device (GLS)
description: The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
arm group label: Erchonia Scanner device (GLS)
intervention type: Device
intervention name: Placebo device
description: Inactive Erchonia GLS.
arm group label: Placebo device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory C Roche, D.O.
role: Principal Investigator
last name: Robert F Jackson, M.D.
role: Principal Investigator
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cellulite
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 