<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/NCT02980783</url>
  </required_header>
  <id_info>
    <org_study_id>GMA-EAME-FAS-0397</org_study_id>
    <nct_id>NCT02980783</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions</brief_title>
  <acronym>BEAM</acronym>
  <official_title>BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic&#xD;
      radial cheek line skin depressions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">December 14, 2016</completion_date>
  <primary_completion_date type="Actual">December 14, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire</measure>
    <time_frame>Baseline (Day 1) to Day 45</time_frame>
    <description>The SPA questionnaire consists of one question: &quot;How do you think your facial appearance looks compared to your age TODAY?&quot; Participants could choose one of three possible answers: &quot;I look my current age,&quot; &quot;I look younger,&quot; or &quot;I look older.&quot; The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire</measure>
    <time_frame>Day 45</time_frame>
    <description>Participants were asked to indicate their level agreement with the following statement: &quot;The treatment of my smile lines gave me a natural look.&quot; Responses were scored from 0 to 10, where 0=not at all to 10=very much.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Cheek Line Depressions</condition>
  <arm_group>
    <arm_group_label>Juvéderm® VOLIFT®™ with Lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Juvéderm® VOLIFT®™ with Lidocaine</intervention_name>
    <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.</description>
    <arm_group_label>Juvéderm® VOLIFT®™ with Lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of dynamic radial cheek lines&#xD;
&#xD;
          -  Agrees not to make any changes to skin care routines, or to have any facial procedures&#xD;
             or treatments during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat,&#xD;
             or other permanent, or semi-permanent dermal fillers or be planning to undergo any of&#xD;
             these procedures during the study&#xD;
&#xD;
          -  Undergone temporary facial dermal filler injections with any substance in the face in&#xD;
             the 12 months prior to study entry&#xD;
&#xD;
          -  Received botulinum toxin therapy of any serotype in any facial area within the&#xD;
             previous 6 months agrees not to receive it during the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graeme Kerson</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratoire DERMSCAN</name>
      <address>
        <city>Lyon</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>January 8, 2018</results_first_submitted>
  <results_first_submitted_qc>September 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 15, 2019</results_first_posted>
  <last_update_submitted>September 25, 2018</last_update_submitted>
  <last_update_submitted_qc>September 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</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>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
          <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population included all participants who were treated with test product at least once.</population>
      <group_list>
        <group group_id="B1">
          <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
          <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="53"/>
          </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="56" spread="7"/>
                  </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="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)</title>
        <description>Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Per Protocol Population included all participants with no major protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)</title>
          <description>Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.</description>
          <population>Per Protocol Population included all participants with no major protocol deviations.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
        <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
          <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.</description>
          <population>Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.</population>
          <units>μm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" spread="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.8" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
        <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
          <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.</description>
          <population>Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.</population>
          <units>μm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203.1" spread="72.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.3" spread="43.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
        <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®</title>
          <description>The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.</description>
          <population>Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.</population>
          <units>μm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="511.8" spread="217.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-115.1" spread="129.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile</title>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>No data was collected because wrinkle volume was not applicable.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile</title>
          <population>No data was collected because wrinkle volume was not applicable.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS</title>
        <description>The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Per Protocol Population included all participants with no major protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS</title>
          <description>The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.</description>
          <population>Per Protocol Population included all participants with no major protocol deviations.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Responder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire</title>
        <description>The SPA questionnaire consists of one question: &quot;How do you think your facial appearance looks compared to your age TODAY?&quot; Participants could choose one of three possible answers: &quot;I look my current age,&quot; &quot;I look younger,&quot; or &quot;I look older.&quot; The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.</description>
        <time_frame>Baseline (Day 1) to Day 45</time_frame>
        <population>Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire</title>
          <description>The SPA questionnaire consists of one question: &quot;How do you think your facial appearance looks compared to your age TODAY?&quot; Participants could choose one of three possible answers: &quot;I look my current age,&quot; &quot;I look younger,&quot; or &quot;I look older.&quot; The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.</description>
          <population>Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day) 1: I look my current age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Day) 1: I look younger</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Day) 1: I look older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45: I look my current age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45: I look younger</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45: I look older</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire</title>
        <description>Participants were asked to indicate their level agreement with the following statement: &quot;The treatment of my smile lines gave me a natural look.&quot; Responses were scored from 0 to 10, where 0=not at all to 10=very much.</description>
        <time_frame>Day 45</time_frame>
        <population>Per Protocol Population included all participants with no major protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
            <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire</title>
          <description>Participants were asked to indicate their level agreement with the following statement: &quot;The treatment of my smile lines gave me a natural look.&quot; Responses were scored from 0 to 10, where 0=not at all to 10=very much.</description>
          <population>Per Protocol Population included all participants with no major protocol deviations.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 59 Days after the First Injection</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Juvéderm® VOLIFT®™ With Lidocaine</title>
          <description>Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.</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="53"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <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="31" subjects_at_risk="53"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="53"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="53"/>
              </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>A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head,</name_or_title>
      <organization>Allergan, Inc</organization>
      <phone>714-246-4500</phone>
      <email>clinicaltrials@allergan.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/NCT02980783
org study id: GMA-EAME-FAS-0397
nct id: NCT02980783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic
      radial cheek line skin depressions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
time frame: Baseline (Day 1) to Day 45
description: Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.
measure: Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
time frame: Baseline (Day 1) to Day 45
description: The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.
measure: Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
time frame: Baseline (Day 1) to Day 45
description: The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.
measure: Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®
time frame: Baseline (Day 1) to Day 45
description: The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.
measure: Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile
time frame: Baseline (Day 1) to Day 45
measure: Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS
time frame: Baseline (Day 1) to Day 45
description: The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.
measure: Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire
time frame: Baseline (Day 1) to Day 45
description: The SPA questionnaire consists of one question: "How do you think your facial appearance looks compared to your age TODAY?" Participants could choose one of three possible answers: "I look my current age," "I look younger," or "I look older." The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older.
measure: Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire
time frame: Day 45
description: Participants were asked to indicate their level agreement with the following statement: "The treatment of my smile lines gave me a natural look." Responses were scored from 0 to 10, where 0=not at all to 10=very much.
arm group label: Juvéderm® VOLIFT®™ with Lidocaine
arm group type: Experimental
description: Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine was injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection was determined by the investigator. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 14.
intervention type: Device
intervention name: Juvéderm® VOLIFT®™ with Lidocaine
description: Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
arm group label: Juvéderm® VOLIFT®™ with Lidocaine
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Graeme Kerson
role: Study Director
affiliation: Allergan
facility: 
country: France
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Lidocaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 