<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/NCT03753152</url>
  </required_header>
  <id_info>
    <org_study_id>MT07-CN16NLF701</org_study_id>
    <nct_id>NCT03753152</nct_id>
  </id_info>
  <brief_title>Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds</brief_title>
  <official_title>A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</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 clinical investigation is a randomized, evaluator-blind, active controlled,&#xD;
      noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine&#xD;
      when compared with YVOIRE® Volume Plus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4&#xD;
      points in the WSRS and who provided written informed consent are to be included in the&#xD;
      investigation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2018</start_date>
  <completion_date type="Actual">October 16, 2019</completion_date>
  <primary_completion_date type="Actual">April 2, 2019</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>WSRS improvement rate at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>WSRS improvement rate at Week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of WSRS from Week 4, 12, 24, 36, and 52</measure>
    <time_frame>Week 4, 12, 24, 36, and 52</time_frame>
    <description>Change of WSRS from Week 4, 12, 24, 36, and 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WSRS improvement rate on Week 4, 12, 36, and 52</measure>
    <time_frame>Week 4, 12, 36, and 52</time_frame>
    <description>WSRS improvement rate on Week 4, 12, 36, and 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAIS improvement rate on Week 4, 12, 24, 36, and 52</measure>
    <time_frame>Week 4, 12, 24, 36, and 52</time_frame>
    <description>GAIS improvement rate on Week 4, 12, 24, 36, and 52</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Nasolabial Folds</condition>
  <arm_group>
    <arm_group_label>Investigational medical device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuramis® Deep Lidocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>YVOIRE® Volume Plus</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>experimental</intervention_name>
    <description>Neuramis® Deep Lidocaine</description>
    <arm_group_label>Investigational medical device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>comparator</intervention_name>
    <description>YVOIRE® Volume Plus</description>
    <arm_group_label>Comparator device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18 to 75 years of age.&#xD;
&#xD;
          2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on&#xD;
             the WSRS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications,&#xD;
             anti inflammatory medications.&#xD;
&#xD;
          2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal&#xD;
             photorejuvenation on the lower inferior orbital rim for wrinkle correction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinhua XU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huashan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HuaShan hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03753152
org study id: MT07-CN16NLF701
nct id: NCT03753152
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical investigation is a randomized, evaluator-blind, active controlled,
      noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine
      when compared with YVOIRE® Volume Plus.
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4
      points in the WSRS and who provided written informed consent are to be included in the
      investigation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: WSRS improvement rate at Week 24
time frame: Week 24
description: WSRS improvement rate at Week 24
measure: Change of WSRS from Week 4, 12, 24, 36, and 52
time frame: Week 4, 12, 24, 36, and 52
description: Change of WSRS from Week 4, 12, 24, 36, and 52
measure: WSRS improvement rate on Week 4, 12, 36, and 52
time frame: Week 4, 12, 36, and 52
description: WSRS improvement rate on Week 4, 12, 36, and 52
measure: GAIS improvement rate on Week 4, 12, 24, 36, and 52
time frame: Week 4, 12, 24, 36, and 52
description: GAIS improvement rate on Week 4, 12, 24, 36, and 52
arm group label: Investigational medical device
arm group type: Experimental
description: Neuramis® Deep Lidocaine
arm group label: Comparator device
arm group type: Active Comparator
description: YVOIRE® Volume Plus
intervention type: Device
intervention name: experimental
description: Neuramis® Deep Lidocaine
arm group label: Investigational medical device
intervention type: Device
intervention name: comparator
description: YVOIRE® Volume Plus
arm group label: Comparator device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jinhua XU
role: Principal Investigator
affiliation: Huashan Hospital
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No