xml: <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/NCT05986630</url>
    </required_header>
    <id_info>
      <org_study_id>TEO-TPVM-2101</org_study_id>
      <nct_id>NCT05986630</nct_id>
    </id_info>
    <brief_title>Safety and Effectiveness Evaluation of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face</brief_title>
    <acronym>LIFTUP</acronym>
    <official_title>A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM Versus COMPARATOR for the Remodeling of the Lower Face</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teoxane SA</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Teoxane SA</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The clinical study is designed to prospectively evaluate the safety and effectiveness of&#xD;
        TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate&#xD;
        safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower&#xD;
        face.&#xD;
  &#xD;
        Subject will be enrolled in the study based on evaluation of their chin retrusion severity.&#xD;
  &#xD;
        For the purpose of this study, all injections will be done by principal investigators (PIs)&#xD;
        with several years of experience in aesthetic treatment.&#xD;
  &#xD;
        An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the&#xD;
        treatment and the product based on photographs&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 6, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 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>Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator</measure>
      <time_frame>8 weeks</time_frame>
      <description>Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE.&#xD;
  TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being &quot;None/minimal&quot; and 3 being &quot;Severe&quot;</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">155</enrollment>
    <condition>Aging</condition>
    <condition>Chin Retrusion</condition>
    <arm_group>
      <arm_group_label>TEOSYAL® TPVM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>n=116 subjects</description>
    </arm_group>
    <arm_group>
      <arm_group_label>COMPARATOR</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>n= 39 subjects</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TEOSYAL® TPVM</intervention_name>
      <description>Injection of TEOSYAL® TPVM at Baseline&#xD;
  Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.</description>
      <arm_group_label>TEOSYAL® TPVM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>COMPARATOR</intervention_name>
      <description>Injection of a COMPARATOR at Baseline&#xD;
  Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.</description>
      <arm_group_label>COMPARATOR</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adult subjects over 18 years old seeking correction of their lower face&#xD;
  &#xD;
            -  Subject scored grade 2 or 3 on the TCRS&#xD;
  &#xD;
            -  Female subjects of childbearing potential must have a negative UPT and practice a&#xD;
               reliable method of contraception throughout the study.&#xD;
  &#xD;
            -  Willing to abstain from facial aesthetic procedures/therapies that could interfere&#xD;
               with study evaluations&#xD;
  &#xD;
            -  Able to follow study instructions and complete all required visits.&#xD;
  &#xD;
            -  Having given its signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known hypersensitivity or previous allergic reaction to any component of the study&#xD;
               devices&#xD;
  &#xD;
            -  Known sensitivity to local anesthetics of the amide type, history of multiple severe&#xD;
               allergies, or history of anaphylactic shock.&#xD;
  &#xD;
            -  History of active chronic debilitating systemic disease that, in the opinion of the&#xD;
               investigator, would make the subject a poor candidate in the study.&#xD;
  &#xD;
            -  Subject exhibits any physical attribute that may prevent assessment or treatment of&#xD;
               the lower face as judged by the PI&#xD;
  &#xD;
            -  Clinically significant alcohol or drug abuse.&#xD;
  &#xD;
            -  Subject has received any investigational product within 90 days prior to Visit 1 or&#xD;
               planning to participate in another investigation during the course of 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_contact>
      <last_name>Louis Chapu</last_name>
      <phone>+41223449636</phone>
      <email>clinical@teoxane.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Canton - Geneva</name>
        <address>
          <city>Geneva</city>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Site 001 Geneva</last_name>
        <phone>+41223475757</phone>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dermal filler</keyword>
    <keyword>Hyaluronic acid (HA)</keyword>
    <keyword>Chin</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986630
  org study id: TEO-TPVM-2101
  nct id: NCT05986630
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The clinical study is designed to prospectively evaluate the safety and effectiveness of
        TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face
  This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate
        safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower
        face.
  
        Subject will be enrolled in the study based on evaluation of their chin retrusion severity.
  
        For the purpose of this study, all injections will be done by principal investigators (PIs)
        with several years of experience in aesthetic treatment.
  
        An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the
        treatment and the product based on photographs
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator
  time frame: 8 weeks
  description: Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE.
  TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being "None/minimal" and 3 being "Severe"
  arm group label: TEOSYAL® TPVM
  arm group type: Experimental
  description: n=116 subjects
  arm group label: COMPARATOR
  arm group type: Active Comparator
  description: n= 39 subjects
  intervention type: Device
  intervention name: TEOSYAL® TPVM
  description: Injection of TEOSYAL® TPVM at Baseline
  Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
  arm group label: TEOSYAL® TPVM
  intervention type: Device
  intervention name: COMPARATOR
  description: Injection of a COMPARATOR at Baseline
  Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
  arm group label: COMPARATOR
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Louis Chapu
  phone: +41223449636
  email: clinical@teoxane.com
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor