<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/NCT01680497</url>
  </required_header>
  <id_info>
    <org_study_id>MAF/AGN/MED/FIL/018</org_study_id>
    <nct_id>NCT01680497</nct_id>
  </id_info>
  <brief_title>Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM&#xD;
      VOLIFT™ for the correction of moderate to severe nasolabial folds&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">March 6, 2014</completion_date>
  <primary_completion_date type="Actual">March 6, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)</measure>
    <time_frame>Month 12</time_frame>
    <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</measure>
    <time_frame>Day 0, Day 14, Month 1, Month 9</time_frame>
    <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale</measure>
    <time_frame>Day 14, Month 1, Month 9, Month 12</time_frame>
    <description>Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Assessment of Ease of Injection Use on a 10-Point Scale</measure>
    <time_frame>Day 0, Day 14</time_frame>
    <description>Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</measure>
    <time_frame>Day 0, Day 14, Month 1, Month 9, Month 12</time_frame>
    <description>Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale</measure>
    <time_frame>Day 14, Month 1, Month 9, Month 12</time_frame>
    <description>Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale</measure>
    <time_frame>Day 0, Day 14, Month 12, Month 12.5</time_frame>
    <description>Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Moderate to Severe Nasolabial Folds</condition>
  <arm_group>
    <arm_group_label>JUVÉDERM VOLIFT™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Crosslinked hyaluronic acid dermal filler</intervention_name>
    <description>All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.</description>
    <arm_group_label>JUVÉDERM VOLIFT™</arm_group_label>
    <other_name>JUVÉDERM VOLIFT™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 years of age or older&#xD;
&#xD;
          -  Have 2 fully visible, approximately symmetrical nasolabial folds and has severity&#xD;
             scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range&#xD;
             0-4) for both nasolabial folds, as judged by the Investigator&#xD;
&#xD;
          -  Have a reasonable expectation for correction by injection via deep dermis, as&#xD;
             described in the protocol&#xD;
&#xD;
          -  Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower&#xD;
             two-thirds of the face (below the orbital rim) for the duration of the study&#xD;
&#xD;
          -  Understand and be willing to follow all aspects of the study protocol and have signed&#xD;
             and dated the Informed Consent prior to any study-related procedures being performed&#xD;
&#xD;
          -  Be in good health as in the opinion of the Investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which&#xD;
             may alter the appearance of the nasolabial fold area&#xD;
&#xD;
          -  Cosmetic injections in the lower two-thirds of the face (below the orbital rim),&#xD;
             within 6 months prior to entry in the study, or be planning to undergo any of these&#xD;
             procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or&#xD;
             collagen is allowed, provided the treatment was administered more than 6 months prior&#xD;
             to study entry&#xD;
&#xD;
          -  Has undergone volumizing of the mid/lower face within 9 months prior to study entry&#xD;
&#xD;
          -  Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium&#xD;
             hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded&#xD;
             poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be&#xD;
             planning to be implanted with any of these products at any time during the study&#xD;
&#xD;
          -  Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine&#xD;
             (an any amide-based anesthetics), HA products, or Streptococcal protein, or be&#xD;
             planning to undergo a desensitization therapy during the term of the study&#xD;
&#xD;
          -  Be a pregnant female, lactating, or planning to become pregnant at any time during the&#xD;
             study&#xD;
&#xD;
          -  Be a female of childbearing potential not using a reliable means of contraception&#xD;
&#xD;
          -  Have received any investigational product within 30 days prior to study enrollment or&#xD;
             be planning to participate in another investigation during the course of this study&#xD;
&#xD;
          -  Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)&#xD;
&#xD;
          -  Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid&#xD;
             arthritis, Crohn's disease)&#xD;
&#xD;
          -  Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or&#xD;
             without heart complications)&#xD;
&#xD;
          -  Have a history of skin cancer&#xD;
&#xD;
          -  Suffer from porphyria&#xD;
&#xD;
          -  Have epilepsy, which is not controlled by anti-epilepsy therapy&#xD;
&#xD;
          -  Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes)&#xD;
&#xD;
          -  Have a history of treatment with interferon&#xD;
&#xD;
          -  Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken&#xD;
             non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other&#xD;
             substances known to increase coagulation time (e.g., herbal supplements with garlic or&#xD;
             ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device&#xD;
             injection may be delayed as necessary to accommodate this 10-day period&#xD;
&#xD;
          -  Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may&#xD;
             cause acute toxic reactions&#xD;
&#xD;
          -  Be on a concurrent regimen of other local anesthetics structurally related to&#xD;
             amide-type local anesthetics&#xD;
&#xD;
          -  Have impaired cardiac conduction, severely impaired hepatic function, or severe renal&#xD;
             dysfunction&#xD;
&#xD;
          -  Have a condition or be in a situation that, in the Investigator's opinion, may put the&#xD;
             subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly with the subject's participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Allergan Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Darmstadt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Koln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Naarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
  </removed_countries>
  <reference>
    <citation>Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939.</citation>
    <PMID>28165349</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>June 5, 2015</results_first_submitted>
  <results_first_submitted_qc>June 5, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 23, 2015</results_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>JUVÉDERM VOLIFT™</title>
          <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>JUVÉDERM VOLIFT™</title>
          <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
          </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="49.3" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)</title>
        <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
        <time_frame>Month 12</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)</title>
          <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Months - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</title>
        <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
        <time_frame>Day 0, Day 14, Month 1, Month 9</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</title>
          <description>Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 -Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 - Left (N=66</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 - Left (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale</title>
        <description>Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
        <time_frame>Day 14, Month 1, Month 9, Month 12</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale</title>
          <description>Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (N=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (N=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Assessment of Ease of Injection Use on a 10-Point Scale</title>
        <description>Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).</description>
        <time_frame>Day 0, Day 14</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Assessment of Ease of Injection Use on a 10-Point Scale</title>
          <description>Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (N=27)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</title>
        <description>Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
        <time_frame>Day 0, Day 14, Month 1, Month 9, Month 12</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS</title>
          <description>Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 - Left (N=65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 - Left (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 - Right (N=54)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 - Left (N=54)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale</title>
        <description>Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
        <time_frame>Day 14, Month 1, Month 9, Month 12</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale</title>
          <description>Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 (N=54)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale</title>
        <description>Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).</description>
        <time_frame>Day 0, Day 14, Month 12, Month 12.5</time_frame>
        <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
        <group_list>
          <group group_id="O1">
            <title>JUVÉDERM VOLIFT™</title>
            <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale</title>
          <description>Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).</description>
          <population>Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point</population>
          <units>Scores 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="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain Intensity Day 0 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Day 0 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Day 14 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Day 14 - Left (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Month 12 - Right (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Month 12 - Left (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Month 12.5 - Right (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Intensity Month 12.5 - Left (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Day 0 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Day 0 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Day 14 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Day 14 - Left (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Month 12 - Right (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Month 12 - Left (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Month 12.5 - Right (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling Intensity Month 12.5 - Left (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Day 0 - Right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Day 0 - Left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Day 14 - Right (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Day 14 - Left (N=66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Month 12 - Right (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Month 12 - Left (N=51)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Month 12.5 - Right (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising Intensity Month 12.5 - Left (N=12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all treated subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>JUVÉDERM VOLIFT™</title>
          <description>All subjects receiving treatment with JUVÉDERM VOLIFT™.</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="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="70"/>
              </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>Vice President Medical Affairs,</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/NCT01680497
org study id: MAF/AGN/MED/FIL/018
nct id: NCT01680497
lead sponsor: 
has dmc: No
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM
      VOLIFT™ for the correction of moderate to severe nasolabial folds
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
time frame: Month 12
description: Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
measure: Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
time frame: Day 0, Day 14, Month 1, Month 9
description: Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
measure: Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
time frame: Day 14, Month 1, Month 9, Month 12
description: Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
measure: Investigator Assessment of Ease of Injection Use on a 10-Point Scale
time frame: Day 0, Day 14
description: Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
measure: Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
time frame: Day 0, Day 14, Month 1, Month 9, Month 12
description: Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
measure: Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
time frame: Day 14, Month 1, Month 9, Month 12
description: Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
measure: Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
time frame: Day 0, Day 14, Month 12, Month 12.5
description: Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).
arm group label: JUVÉDERM VOLIFT™
arm group type: Experimental
description: All subjects receiving treatment with JUVÉDERM VOLIFT™.
intervention type: Device
intervention name: Crosslinked hyaluronic acid dermal filler
description: All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.
arm group label: JUVÉDERM VOLIFT™
other name: JUVÉDERM VOLIFT™
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Monitor
role: Study Director
affiliation: Allergan Medical
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
country: Belgium
citation: Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939.
PMID: 28165349
responsible party type: Sponsor
mesh term: Hyaluronic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 