<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/NCT03300466</url>
  </required_header>
  <id_info>
    <org_study_id>43FE1630</org_study_id>
    <nct_id>NCT03300466</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds</brief_title>
  <official_title>A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe 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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to assess the performance and safety of GP0045 when injected in the&#xD;
      nasolabial folds.&#xD;
&#xD;
      There is an 18 months follow up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">April 24, 2019</completion_date>
  <primary_completion_date type="Actual">April 27, 2018</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>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</measure>
    <time_frame>2 weeks, 3, 9, 12, 15 and 18 months</time_frame>
    <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Nasolabial Fold</condition>
  <condition>Safety</condition>
  <arm_group>
    <arm_group_label>GP0045</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with GP0045</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment with active comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GP0045</intervention_name>
    <description>Hyaluronic acid gel</description>
    <arm_group_label>GP0045</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comparator</intervention_name>
    <description>Hyaluronic acid gel</description>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to adequately understand the verbal explanations and the written subject&#xD;
             information provided in local language and ability to give consent to participate in&#xD;
             the study&#xD;
&#xD;
          -  Signed and dated informed consent to participate in the study, including photo consent&#xD;
&#xD;
          -  Subjects with intent to undergo correction of both nasolabial folds&#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, e.g. lidocaine or&#xD;
             other amide-type anesthetics&#xD;
&#xD;
          -  Any condition (medical or other) that, in the opinion of the Investigator, would make&#xD;
             the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease&#xD;
             that may interfere with the outcome of the study)&#xD;
&#xD;
          -  Participation in any other clinical study with an investigational product within 30&#xD;
             days before treatment&#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_official>
    <last_name>Q-Med AB</last_name>
    <role>Study Director</role>
    <affiliation>Galderma R&amp;D</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Q-Med</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>March 17, 2020</results_first_submitted>
  <results_first_submitted_qc>April 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 17, 2020</results_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyaluronic Acid, Lidocaine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03300466/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>GP0045 in Right NLF and Comparator in Left NLF</title>
          <description>Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF&#xD;
GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel</description>
        </group>
        <group group_id="P2">
          <title>Comparator in Right NLF and GP0045 in Left NLF</title>
          <description>Treatment with comparator in right NLF and GP0045 in left NLF&#xD;
GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GP0045 in Right NLF and Comparator in Left NLF</title>
          <description>Treatment with GP0045 in right NLF and comparator in left NLF&#xD;
GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel</description>
        </group>
        <group group_id="B2">
          <title>Comparator in Right NLF and GP0045 in Left NLF</title>
          <description>Treatment with comparator in right NLF and GP0045 in left NLF&#xD;
GP0045: Hyaluronic acid gel Comparator: Hyaluronic acid gel</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</title>
        <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GP0045</title>
            <description>Treatment with GP0045&#xD;
GP0045: Hyaluronic acid gel</description>
          </group>
          <group group_id="O2">
            <title>Comparator</title>
            <description>Treatment with comparator&#xD;
Comparator: Hyaluronic acid gel</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</title>
          <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.2"/>
                    <measurement group_id="O2" value="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</title>
        <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
        <time_frame>2 weeks, 3, 9, 12, 15 and 18 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GP0045</title>
            <description>Treatment with GP0045&#xD;
GP0045: Hyaluronic acid gel</description>
          </group>
          <group group_id="O2">
            <title>Comparator</title>
            <description>Treatment with comparator&#xD;
Comparator: Hyaluronic acid gel</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale</title>
          <description>The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.5"/>
                    <measurement group_id="O2" value="89.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.8"/>
                    <measurement group_id="O2" value="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                    <measurement group_id="O2" value="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5"/>
                    <measurement group_id="O2" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18-19 months (depending on how long screening), from screening visit to final study visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GP0045 in Right NLF and Comparator in Left NLF</title>
          <description>Treatment with GP0045 in right NLF (nasolabial fold) and comparator in left NLF</description>
        </group>
        <group group_id="E2">
          <title>Comparator in Right NLF and GP0045 in Left NLF</title>
          <description>Treatment with comparator in right NLF and GP0045 in left NLF</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye allergy</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Iritis</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oral disorder</sub_title>
                <description>Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045).</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gingival recession</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Implant site erythema</sub_title>
                <description>Related to study product or injection procedure. One event in right NLF (treated with comparator) and one event in left NLF (treated with GP0045).</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site hypoesthesia</sub_title>
                <description>Related to study product or injection procedure. In left NLF (treated with GP0045).</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site mass</sub_title>
                <description>Related to study product or injection procedure. Both events in the NLF treated with GP0045.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site pain</sub_title>
                <description>Related to study product/injection. 9 events (5 participants) in the NLF treated with GP0045, 8 events (4 participants) in the NLF treated with comparator. (1 participant can report one event in left NLF and one event in right NLF at the same time.)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="17" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site papules</sub_title>
                <description>Related to study product or injection procedure. In the NLF treated with GP0045.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site pruritus</sub_title>
                <description>Related to study product or injection procedure. One event in the NLF treated with GP0045 and one event in the NLF treated with comparator.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Implant site swelling</sub_title>
                <description>Related to study product/injection. 9 events (3 participants) in NLF treated with GP0045, 2 events (2 participants) in the NLF treated with comparator. (1 participant can report 1 event in the right NLF and 1 event in the left NLF at the same time).</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="11" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperlipidemia</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Overweight</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <description>Unrelated to study product/study product injection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Project Manager</name_or_title>
      <organization>Q-Med AB</organization>
      <phone>+46184749000</phone>
      <email>reception.seupp@galderma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03300466
org study id: 43FE1630
nct id: NCT03300466
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study to assess the performance and safety of GP0045 when injected in the
      nasolabial folds.

      There is an 18 months follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
time frame: 6 months
description: The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
measure: Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
time frame: 2 weeks, 3, 9, 12, 15 and 18 months
description: The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
arm group label: GP0045
arm group type: Experimental
description: Treatment with GP0045
arm group label: Comparator
arm group type: Active Comparator
description: Treatment with active comparator
intervention type: Device
intervention name: GP0045
description: Hyaluronic acid gel
arm group label: GP0045
intervention type: Device
intervention name: Comparator
description: Hyaluronic acid gel
arm group label: Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Q-Med AB
role: Study Director
affiliation: Galderma R&D
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 