<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/NCT03241862</url>
  </required_header>
  <id_info>
    <org_study_id>Silk-FI-01</org_study_id>
    <nct_id>NCT03241862</nct_id>
  </id_info>
  <brief_title>Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions</brief_title>
  <official_title>Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DeNova Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DeNova Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      20 subjects with mild to severe oral commissures or none to severe perioral lines will be&#xD;
      enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days&#xD;
      after Optimal Cosmetic Results has been achieved, as judged by the investigator.&#xD;
&#xD;
      Changes in the projected first impression will be assessed by a total of 200 blinded&#xD;
      evaluators rating the photographs of subjects from the baseline and from 14 days post&#xD;
      achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed&#xD;
      through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic&#xD;
      alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale,&#xD;
      Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the&#xD;
      self-assessment of subjects using the Global Aesthetic Improvement Scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">June 16, 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First Impressions</measure>
    <time_frame>1 month</time_frame>
    <description>The projected first impressions are assessed by blinded evaluators using photographs.&#xD;
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).&#xD;
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appearance of the Lip and Perioral Area</measure>
    <time_frame>Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)</time_frame>
    <description>Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4&#xD;
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)&#xD;
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Lip Rejuvenation</condition>
  <arm_group>
    <arm_group_label>Restylane® Silk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Restylane® Silk</intervention_name>
    <description>Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
    <arm_group_label>Restylane® Silk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is an adult of at least 21 years of age;&#xD;
&#xD;
          -  Subject has mild to severe oral commissures or none to severe perioral lines, as&#xD;
             assessed by the treating investigator;&#xD;
&#xD;
          -  Subject is willing and able to provide written informed consent prior to the&#xD;
             performance of any study related procedure;&#xD;
&#xD;
          -  Subject is willing and able to comply with the protocol requirements; and&#xD;
&#xD;
          -  Subject is willing and able to provide written photo consent and adhere to the&#xD;
             photography and video procedures such as removal of jewelry and makeup&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received lip filler treatments in the past 12 months or neurotoxin&#xD;
             injections in the past 6 months;&#xD;
&#xD;
          -  Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial&#xD;
             cosmetic surgery, or other injectable filler treatments during the course of the&#xD;
             study;&#xD;
&#xD;
          -  Subjects with a known allergy or sensitivity to any component of the study&#xD;
             ingredients;&#xD;
&#xD;
          -  Subjects with a history of bleeding disorders;&#xD;
&#xD;
          -  Female subjects who are pregnant or nursing as well as those who are of childbearing&#xD;
             potential but do not employ adequate birth control methods;&#xD;
&#xD;
          -  Subjects with severe allergies manifested by a history of anaphylaxis or presence of&#xD;
             multiple severe allergies;&#xD;
&#xD;
          -  Subjects with previous history of sensitivity to amide type local anesthetics;&#xD;
&#xD;
          -  Current history of chronic drug or alcohol abuse;&#xD;
&#xD;
          -  Concurrent therapy that, in the investigator's opinion, would interfere with the&#xD;
             evaluation of the safety or efficacy of the study product;&#xD;
&#xD;
          -  Subjects who, in the investigator's opinion, have a history of poor cooperation,&#xD;
             non-compliance with medical treatment, or unreliability; and&#xD;
&#xD;
          -  Enrollment in any active study involving the use of investigational devices or drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven H Dayan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DeNova Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DeNova Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 14, 2015</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>November 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2020</results_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>June 11, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03241862/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Restylane® Silk</title>
          <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.&#xD;
Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Restylane® Silk</title>
          <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.&#xD;
Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" 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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Impressions</title>
        <description>The projected first impressions are assessed by blinded evaluators using photographs.&#xD;
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).&#xD;
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.</description>
        <time_frame>1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Restylane® Silk</title>
            <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.&#xD;
Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
          </group>
        </group_list>
        <measure>
          <title>First Impressions</title>
          <description>The projected first impressions are assessed by blinded evaluators using photographs.&#xD;
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).&#xD;
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>lips first impressions</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>lips first impressions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Social skills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.756" spread="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Academic Performance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.769" spread="0.887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dating success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.391" spread="0.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occupational success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.404" spread="0.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attractiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.612" spread="0.544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Financial success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.029" spread="0.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relationship success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.245" spread="0.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Athletic success</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.433" spread="0.835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Appearance of the Lip and Perioral Area</title>
        <description>Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4&#xD;
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)&#xD;
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest</description>
        <time_frame>Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Restylane® Silk</title>
            <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.&#xD;
Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
          </group>
        </group_list>
        <measure>
          <title>Appearance of the Lip and Perioral Area</title>
          <description>Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4&#xD;
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)&#xD;
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="0.502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3/4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="0.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Restylane® Silk</title>
          <description>All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.&#xD;
Restylane® Silk: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.</description>
        </group>
      </group_list>
      <serious_events>
        <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="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT 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>Steven Dayan, MD</name_or_title>
      <organization>DeNova Research</organization>
      <phone>3123352070</phone>
      <email>sdayan@drdayan.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/NCT03241862
org study id: Silk-FI-01
nct id: NCT03241862
lead sponsor: 
has dmc: No
20 subjects with mild to severe oral commissures or none to severe perioral lines will be
      enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days
      after Optimal Cosmetic Results has been achieved, as judged by the investigator.

      Changes in the projected first impression will be assessed by a total of 200 blinded
      evaluators rating the photographs of subjects from the baseline and from 14 days post
      achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed
      through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic
      alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale,
      Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the
      self-assessment of subjects using the Global Aesthetic Improvement Scale.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: First Impressions
time frame: 1 month
description: The projected first impressions are assessed by blinded evaluators using photographs.
The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ).
Each of the below First Impression Questionnaire (FIQ) categories is scored between 1 (disagree)-10 (agree) and a total of 8 categories (see below) are assessed for a total possible score of 80. All scores will be graded out of a total possible score of 80 points Social skills Academic Performance Dating Success Occupational success Attractiveness Financial Success Relationship success Athletic success Total scores closer to 80 indicate a more favorable outcome.
measure: Appearance of the Lip and Perioral Area
time frame: Visit 1 at Baseline and Visit 3 (Week 4) or Visit 4 (Week 6)
description: Changes in the appearance of the lip and the perioral area are assessed by the PI using the Oral Commissure Severity Scale (OCSS) at Visit 1 and Visit 3/4
Oral Commissure Severity Scale (OCSS): graded from None (0), Mild (1), Moderate (2), Severe (3)
None: No wrinkle or fold; slight upturned commissures Mild: Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners Moderate: Moderately deep and/or long wrinkle or crease; downturned corners Severe: Very deep and/or long wrinkle or crease; frown at rest
arm group label: Restylane® Silk
arm group type: Experimental
description: All subjects enrolled in the study will undergo lip rejuvenation treatment with Restylane® Silk.
intervention type: Device
intervention name: Restylane® Silk
description: Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
arm group label: Restylane® Silk
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Steven H Dayan, MD
role: Principal Investigator
affiliation: DeNova Research
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 