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/NCT05987163</url>
    </required_header>
    <id_info>
      <org_study_id>43N3US2204</org_study_id>
      <nct_id>NCT05987163</nct_id>
    </id_info>
    <brief_title>Study to Evaluate the Safety and Effectiveness of GP0116</brief_title>
    <acronym>NLF</acronym>
    <official_title>A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as 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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group,&#xD;
        multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles&#xD;
        and folds, such as nasolabial folds (NLFs).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 12, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 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>To demonstrate non-inferiority of GP0116 versus a comparator control</measure>
      <time_frame>At 3 months after Baseline</time_frame>
      <description>To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">186</enrollment>
    <condition>Skin Manifestations</condition>
    <arm_group>
      <arm_group_label>GP0116</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>FDA Approved Device</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>GP0116</intervention_name>
      <description>GP0116 is an injectable, sterile, transparent product.</description>
      <arm_group_label>GP0116</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Active Comparator: FDA approved dermal filler device</intervention_name>
      <description>FDA approved dermal filler device</description>
      <arm_group_label>FDA Approved Device</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and non-pregnant, non-breastfeeding women aged 22 years or older.&#xD;
  &#xD;
            -  WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded&#xD;
               Evaluator. The WSRS for each NLF does not need to be equal.&#xD;
  &#xD;
            -  Intent to undergo treatment for correction of both left and right NLF.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel&#xD;
  &#xD;
            -  Known/previous allergy or hypersensitivity to local anesthetics&#xD;
  &#xD;
            -  Previous or present severe or multiple allergies manifested by severe reactions&#xD;
  &#xD;
            -  Previous facial surgery near the treatment area&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Galderma Investigational Site (Site#8126)</name>
        <address>
          <city>West Palm Beach</city>
          <state>Florida</state>
          <zip>33401</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Galderma Investigational Site (Site#8580)</name>
        <address>
          <city>New Orleans</city>
          <state>Louisiana</state>
          <zip>70130</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Galderma Investigational Site (Site#8783)</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45236</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Skin Manifestations</mesh_term>
    </condition_browse>
    <!-- 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/NCT05987163
  org study id: 43N3US2204
  nct id: NCT05987163
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group,
        multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles
        and folds, such as nasolabial folds (NLFs).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: To demonstrate non-inferiority of GP0116 versus a comparator control
  time frame: At 3 months after Baseline
  description: To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).
  arm group label: GP0116
  arm group type: Experimental
  arm group label: FDA Approved Device
  arm group type: Active Comparator
  intervention type: Device
  intervention name: GP0116
  description: GP0116 is an injectable, sterile, transparent product.
  arm group label: GP0116
  intervention type: Device
  intervention name: Active Comparator: FDA approved dermal filler device
  description: FDA approved dermal filler device
  arm group label: FDA Approved Device
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Skin Manifestations