<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/NCT02216851</url>
  </required_header>
  <id_info>
    <org_study_id>43CH1310</org_study_id>
    <nct_id>NCT02216851</nct_id>
  </id_info>
  <brief_title>Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root</brief_title>
  <official_title>A Randomized, Open Label, No-treatment Controlled, Multi-center, Efficacy and Safety Study Using Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of using Restylane Perlane&#xD;
      to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control</measure>
    <time_frame>6 months</time_frame>
    <description>The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique.&#xD;
The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Nasal Augmentation</condition>
  <arm_group>
    <arm_group_label>Restylane Perlane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single injection of Restylane Perlane in nasal dorsum and/or nasal root</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-treatment control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No-treatment control group do not receive any treatment during the main study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane Perlane</intervention_name>
    <description>Intradermal injection</description>
    <arm_group_label>Restylane Perlane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese origin&#xD;
&#xD;
          -  Subject with desire to shape the nasal dorsum and/or nasal root&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can achieve a clinically meaningful&#xD;
             aesthetic correction of their nose with ≤ 1 ml Restylane Perlane&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with previous nasal surgery, including grafts or implants to the nose area&#xD;
&#xD;
          -  Subjects requiring filler treatment around the tip of the nose or between the eyebrows&#xD;
             (glabella region) to achieve a good aesthetic outcome&#xD;
&#xD;
          -  Subjects with a history of chronic sinusitis or rhinitis&#xD;
&#xD;
          -  Subjects who have previously received aesthetic treatment in the forehead, glabellar&#xD;
             and/or nose area with a dermal filler&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</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>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>July 5, 2021</results_first_submitted>
  <results_first_submitted_qc>September 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 23, 2021</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</keyword>
  <keyword>no-treatment control</keyword>
  <keyword>enhancement</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Restylane Perlane</title>
          <description>Single injection of Restylane Perlane in nasal dorsum and/or nasal root&#xD;
Restylane Perlane: Intradermal injection</description>
        </group>
        <group group_id="P2">
          <title>No-treatment Control</title>
          <description>No-treatment control group do not receive any treatment during the main study period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Restylane Perlane</title>
          <description>Single injection of Restylane Perlane in nasal dorsum and/or nasal root&#xD;
Restylane Perlane: Intradermal injection</description>
        </group>
        <group group_id="B2">
          <title>No-treatment Control</title>
          <description>No-treatment control group do not receive any treatment during the main study period</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="98"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="131"/>
          </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="98"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="94"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="131"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control</title>
        <description>The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique.&#xD;
The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Restylane Perlane</title>
            <description>Single injection of Restylane Perlane in nasal dorsum and/or nasal root&#xD;
Restylane Perlane: Intradermal injection</description>
          </group>
          <group group_id="O2">
            <title>No-treatment Control</title>
            <description>No-treatment control group do not receive any treatment during the main study period</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control</title>
          <description>The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique.&#xD;
The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="0.03"/>
                    <measurement group_id="O2" value="0.11" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During study participation, up to 12 months.</time_frame>
      <desc>Each subject was questioned about AEs at each clinical visit starting at the treatment visit, Visit 2. The question asked was &quot;Since your last clinical visit have you had any health problems?&quot; Information on AEs could also be obtained from signs and symptoms detected during each examination, observations by the study personnel, reactions recorded in the subject diary that were ongoing on Day 14 or spontaneous reports from the subjects during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Restylane Perlane</title>
          <description>Single injection of Restylane Perlane in nasal dorsum and/or nasal root&#xD;
Restylane Perlane: Intradermal injection</description>
        </group>
        <group group_id="E2">
          <title>No-treatment Control</title>
          <description>No-treatment control group do not receive any treatment during the main study period</description>
        </group>
      </group_list>
      <serious_events>
        <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="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Solid pseudopapillary tumor of the pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>mixed hemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Fallopian tube obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>peritoneal adhesions</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="98"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="98"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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>Head of Development</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/NCT02216851
org study id: 43CH1310
nct id: NCT02216851
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane
      to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean Difference of Change in Volume (mL) at 6 Months After Baseline Versus Pre-treatment in the Nasal Dorsum/Nasal Root Between Restylane Perlane Treatment Group and No-treatment Control
time frame: 6 months
description: The primary objective of the study was to evaluate the efficacy of Restylane Perlane in shaping the nasal dorsum and/or nasal root as compared to no-treatment control, by assessment of the primary endpoint:The change in volume will be measured using 3 D photography technique.
The change in volume was calculated as the value at 6 months of treatment group compared with non-treatment group
arm group label: Restylane Perlane
arm group type: Experimental
description: Single injection of Restylane Perlane in nasal dorsum and/or nasal root
arm group label: No-treatment control
arm group type: No Intervention
description: No-treatment control group do not receive any treatment during the main study period
intervention type: Device
intervention name: Restylane Perlane
description: Intradermal injection
arm group label: Restylane Perlane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Q-Med AB
role: Study Director
affiliation: Galderma R&D
facility: 
facility: 
country: China
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 