<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/NCT03754413</url>
  </required_header>
  <id_info>
    <org_study_id>MT08-CN16MFV702</org_study_id>
    <nct_id>NCT03754413</nct_id>
  </id_info>
  <brief_title>Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face</brief_title>
  <official_title>A Multicenter Randomized, Evaluator-Blinded, &quot;No Treatment&quot; Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face</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>
      To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume&#xD;
      augmentation in the mid-face.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, evaluator-blinded, &quot;no-treatment&quot; controlled study&#xD;
      conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236&#xD;
      male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume&#xD;
      augmentation to correct deficit in their mid-face volume.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2018</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">March 9, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Facial Volume Scale(FVS) improvement rate at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52</measure>
    <time_frame>Weeks 4, 12, 36, and 52</time_frame>
    <description>The proportion of subjects with 6-point Facial Volume Scale(FVS) decrease ≥1 from Baseline as assessed at Weeks 4, 12, 36, and 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52</measure>
    <time_frame>Weeks 4, 12, 24, 36, and 52</time_frame>
    <description>Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52</measure>
    <time_frame>Weeks 4, 12, 24, 36, and 52</time_frame>
    <description>Global Aesthetic Improvement Scale(GAIS) improvement rate is defined as the proportion of subjects with GAIS score ≤3</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Mid Face Volume Loss</condition>
  <arm_group>
    <arm_group_label>Investigational medical device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuramis® Volume Lidocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No-treatment</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>Drug</intervention_type>
    <intervention_name>comparator</intervention_name>
    <description>No-treatment</description>
    <arm_group_label>Comparator device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 20 to 75 years of age&#xD;
&#xD;
          2. Subjects who desire volume augmentation to correct deficit in the mid-face volume that&#xD;
             is rated as Grade 3, 4, or 5 on the Facial Volume Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have received anti coagulation, anti-platelet, or thrombolytic&#xD;
             medications, anti-inflammatory drugs.&#xD;
&#xD;
          2. Subjects who have undergone facial plastic surgery in the face area below the level of&#xD;
             the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or&#xD;
             other permanent, or semi-permanent dermal fillers or are planning to undergo any of&#xD;
             these procedures at any time during the clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Hopsital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</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 27, 2018</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03754413
org study id: MT08-CN16MFV702
nct id: NCT03754413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume
      augmentation in the mid-face.
This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study
      conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236
      male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume
      augmentation to correct deficit in their mid-face volume.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Total Facial Volume Scale(FVS) improvement rate at Week 24
time frame: Week 24
description: Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline
measure: 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52
time frame: Weeks 4, 12, 36, and 52
description: The proportion of subjects with 6-point Facial Volume Scale(FVS) decrease ≥1 from Baseline as assessed at Weeks 4, 12, 36, and 52.
measure: Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
time frame: Weeks 4, 12, 24, 36, and 52
description: Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
measure: Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52
time frame: Weeks 4, 12, 24, 36, and 52
description: Global Aesthetic Improvement Scale(GAIS) improvement rate is defined as the proportion of subjects with GAIS score ≤3
arm group label: Investigational medical device
arm group type: Experimental
description: Neuramis® Volume Lidocaine
arm group label: Comparator device
arm group type: Other
description: No-treatment
intervention type: Device
intervention name: experimental
description: Neuramis® Deep Lidocaine
arm group label: Investigational medical device
intervention type: Drug
intervention name: comparator
description: No-treatment
arm group label: Comparator device
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor