<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/NCT03003130</url>
  </required_header>
  <id_info>
    <org_study_id>43CH1508</org_study_id>
    <nct_id>NCT03003130</nct_id>
  </id_info>
  <brief_title>Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds</brief_title>
  <official_title>A Randomized, Multi-center, Evaluator-blinded Study to Evaluate the Efficacy and Safety of Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galderma R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Galderma R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, split face, multicenter study to evaluate the efficacy and safety of&#xD;
      Restylane Defyne compared to Restylane in correction of NLFs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">September 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.</measure>
    <time_frame>6 month</time_frame>
    <description>The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds.&#xD;
Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Nasolabial Folds in Chinese Population</condition>
  <arm_group>
    <arm_group_label>Restylane Defyne</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single injection and optional touch up injection with Restylane Defyne in NLF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restylane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single injection and optional touch up injection with Restylane in NLF</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane Defyne</intervention_name>
    <description>Intradermal injection</description>
    <arm_group_label>Restylane Defyne</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane</intervention_name>
    <description>Intradermal injection</description>
    <arm_group_label>Restylane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent.&#xD;
&#xD;
          2. Men or women aged 18 years of age or older of Chinese origin.&#xD;
&#xD;
          3. Subjects willing to abstain from any other facial plastic surgical or cosmetic&#xD;
             procedures below the level of the lower orbital rim for the duration of the study.&#xD;
&#xD;
          4. Intent to undergo correction of both NLFs with a wrinkle severity in WSRS of either 3&#xD;
             on both sides or 4 on both sides, as assessed by the blinded evaluator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel&#xD;
             and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.&#xD;
&#xD;
          2. Previous tissue revitalization treatment below the level of the lower orbital rim&#xD;
             within 6 months before treatment.&#xD;
&#xD;
          3. Previous surgery or tattoo in the area to be treated.&#xD;
&#xD;
          4. Previous tissue augmentation therapy or contouring with any permanent&#xD;
             (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous&#xD;
             fat or permanent implant below the level of the lower orbital rim.&#xD;
&#xD;
          5. Previous use of neurotoxins or any hyaluronic acid based or collagen based&#xD;
             biodegradable facial tissue augmentation therapy below the level of the lower orbital&#xD;
             rim within 12 months before treatment.&#xD;
&#xD;
          6. Scars or deformities, active skin disease, inflammation or related conditions such as&#xD;
             infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne,&#xD;
             psoriasis, and herpes zoster near or in the area to be treated.&#xD;
&#xD;
          7. Other condition preventing the subject from entering the study in the Investigator's&#xD;
             opinion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Q-Med AB</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <results_first_submitted>November 4, 2020</results_first_submitted>
  <results_first_submitted_qc>May 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2021</results_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyaluronic acid</keyword>
  <keyword>Comparative study</keyword>
  <keyword>NLF</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03003130/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03003130/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Each subject have 2 NLFs, the right/left one. According to protocol that Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the right NLF followed by Restylane in the left NLF, or Restylane in the right NLF followed by Restylane Defyne in the left NLF. Arms/Groups are combined because right/left side is not statistical factors.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF</title>
          <description>Restylane Defyne treated in the right NLF followed by Restylane in the left NLF</description>
        </group>
        <group group_id="P2">
          <title>Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF</title>
          <description>Restylane treated in the right NLF followed by Restylane Defyne in the left NLF</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Each subject will be randomized to one of two treatment sequences; either Restylane Defyne in the subject's right NLF followed by Restylane in the subject's left NLF, or Restylane in the subject's right NLF followed by Restylane Defyne in the subject's left NLF.</population>
      <group_list>
        <group group_id="B1">
          <title>Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF</title>
          <description>Restylane Defyne treated in the right NLF followed by Restylane in the left NLF</description>
        </group>
        <group group_id="B2">
          <title>Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF</title>
          <description>Restylane treated in the right NLF followed by Restylane Defyne in the left NLF</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
            <count group_id="B2" value="87"/>
            <count group_id="B3" value="175"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="44" spread="8.7"/>
                    <measurement group_id="B2" value="44" spread="8.7"/>
                    <measurement group_id="B3" value="NA" spread="NA">This data is not applicable for study.</measurement>
                  </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="83"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.</title>
        <description>The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds.&#xD;
Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Restylane Defyne in the Right NLF Followed by Restylane in the Left NLF</title>
            <description>Restylane Defyne treated in the right NLF followed by Restylane in the left NLF</description>
          </group>
          <group group_id="O2">
            <title>Restylane in the Right NLF Followed by Restylane Defyne in the Left NLF</title>
            <description>Restylane treated in the right NLF followed by Restylane Defyne in the left NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.</title>
          <description>The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds.&#xD;
Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.9" lower_limit="66.3" upper_limit="79.6"/>
                    <measurement group_id="O2" value="72.8" lower_limit="66.1" upper_limit="79.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year.</time_frame>
      <desc>According to the subject's treatment randomization.Each subject should be questioned about AEs at each study visit following the screening visit. The question asked should be: &quot;Since your last clinical visit have you had any health problems?&quot;, and or obtained from signs and symptoms from examination, lab test, self observations, diary or spontaneous reports from subject. Since each subject will receive Restylane and Restylane Defyne, then AE was collected per subject, not per intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>Restylane Defyne</title>
          <description>Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.</description>
        </group>
        <group group_id="E2">
          <title>Restylane</title>
          <description>Since all participants received both Restylane and Restylane Defyne treatments, the appropriate way to present Adverse Events to include two Arms eflecting all participants who received each intervention during the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="175"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="175"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment*</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="175"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Traumatic arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="175"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="175"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="175"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="175"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="175"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of Development</name_or_title>
      <organization>Q-Med AB</organization>
      <phone>+ 46 (0) 18 474 90 00</phone>
      <email>reception.seupp@galderma.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/NCT03003130
org study id: 43CH1508
nct id: NCT03003130
lead sponsor: 
has dmc: No
This is a randomized, split face, multicenter study to evaluate the efficacy and safety of
      Restylane Defyne compared to Restylane in correction of NLFs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.
time frame: 6 month
description: The Wrinkle Severity Rating Scale (WSRS) is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds.
Grade 1 Absent: No visible fold; continuous skin line Grade 2 Mild: Shallow but visible fold with a slight indentation; minor facial feature Implant is expected to produce a slight improvement in appearance Grade 3 Moderate: Moderately deep folds; clear facial feature visible at normal appearance but not when stretched. Excellent correction is expected from injectable implant Grade 4 Severe: Very long and deep fold; prominent facial feature; less than 2-mm visible fold when stretched Significant improvement is expected from injectable implant Grade 5 Extreme: Extremely deep and long fold; detrimental to facial appearance; 2- to 4-mm V-shaped fold when stretched. Unlikely to have satisfactory correction with injectable implant alone
arm group label: Restylane Defyne
arm group type: Experimental
description: Single injection and optional touch up injection with Restylane Defyne in NLF
arm group label: Restylane
arm group type: Active Comparator
description: Single injection and optional touch up injection with Restylane in NLF
intervention type: Device
intervention name: Restylane Defyne
description: Intradermal injection
arm group label: Restylane Defyne
intervention type: Device
intervention name: Restylane
description: Intradermal injection
arm group label: Restylane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Hyaluronic Acid
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 