<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/NCT04437745</url>
  </required_header>
  <id_info>
    <org_study_id>LG-HACL022</org_study_id>
    <nct_id>NCT04437745</nct_id>
  </id_info>
  <brief_title>To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face</brief_title>
  <official_title>A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Chem</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Chem</source>
  <oversight_info>
    <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 YVOIRE Y-Solution 720 Injected Into the Mid-Face&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 25, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate</measure>
    <time_frame>26 weeks from baseline</time_frame>
    <description>the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Volume Defects in the Mid-face</condition>
  <arm_group>
    <arm_group_label>YVOIRE Y-Solution 720</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyaluronic acid dermal filler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>YVOIRE Y-Solution 720</intervention_name>
    <description>Hyaluronic acid dermal filler</description>
    <arm_group_label>YVOIRE Y-Solution 720</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adults 18 to 65 years of age (inclusive)&#xD;
&#xD;
          -  3 (moderate) or 4 (severe) on MFVDA-SRS&#xD;
&#xD;
          -  sign the written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have streptococcal disease or bleeding disorder&#xD;
&#xD;
          -  have an active or infective skin disease, scars, or tumor on mid-face&#xD;
&#xD;
          -  have congenital defect, trauma, abnormalities in adipose tissue related to&#xD;
             immune-mediated diseases&#xD;
&#xD;
          -  have undergone facial plastic surgery, tissue grafting, or tissue augmentation with&#xD;
             silicone, fat, or other permanent, or semi-permanent procedures/treatment&#xD;
&#xD;
          -  have undergone temporary facial dermal filler within 12 months, porcine-based collagen&#xD;
             fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing&#xD;
             within 6 months&#xD;
&#xD;
          -  have a medical history of hypertrophic cicatrix or keloid&#xD;
&#xD;
          -  have radiation therapy experience on mid-face&#xD;
&#xD;
          -  have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to&#xD;
             lidocaine, hyaluronic acid products, or Streptococcal protein&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojun Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</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/NCT04437745
org study id: LG-HACL022
nct id: NCT04437745
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
time frame: 26 weeks from baseline
description: the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)
arm group label: YVOIRE Y-Solution 720
arm group type: Experimental
description: Hyaluronic acid dermal filler
arm group label: Control
arm group type: No Intervention
description: No Intervention
intervention type: Device
intervention name: YVOIRE Y-Solution 720
description: Hyaluronic acid dermal filler
arm group label: YVOIRE Y-Solution 720
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaojun Wang
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor