<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/NCT02991040</url>
  </required_header>
  <id_info>
    <org_study_id>SYM2016-02</org_study_id>
    <nct_id>NCT02991040</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse® Ultra + (With Lidocaine) Versus Revanesse® Ultra for the Correction of Nasolabial Folds (NLF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prollenium Medical Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prollenium Medical Technologies Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy&#xD;
      of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of&#xD;
      Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with&#xD;
      lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects&#xD;
      undergoing correction of nasolabial folds (NLFs)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, multicenter, double-blind, split-face study in subjects seeking&#xD;
      nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one&#xD;
      side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of&#xD;
      the face for each study product will be randomly assigned. The investigator and the subject&#xD;
      will be blinded to the treatment; injections of the study product will be performed by an&#xD;
      unblinded injecting investigator.&#xD;
&#xD;
      At each visit, investigator and subject evaluations of the treated areas will be performed&#xD;
      and recorded&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 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>
    <intervention_model_description>Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Revanesse Ultra+ in the NLF on the other side of the face. The side of the face for each study product was randomly assigned.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The side of the face for each product was randomly assigned. The investigator performing the evaluations and the subject were blinded to the treatment; injections of the study product were performed by an unblinded injecting investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection</measure>
    <time_frame>at injection Time 0</time_frame>
    <description>Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection</measure>
    <time_frame>15, 30, 45, and 60 minutes post injection and at 2 weeks post injection</time_frame>
    <description>Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wrinkle Severity Rating Score (WSRS)</measure>
    <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
    <description>The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Aesthetic Improvement</measure>
    <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
    <description>Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Aesthetic Improvement</measure>
    <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
    <description>Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events</measure>
    <time_frame>at injection, Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
    <description>study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Nasolabial Fold Correction</condition>
  <arm_group>
    <arm_group_label>Revanesse Ultra+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Revanesse Ultra+ (with lidocaine)</intervention_name>
    <description>Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)</description>
    <arm_group_label>Revanesse Ultra+</arm_group_label>
    <other_name>Revanesse Versa+</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Revanesse Ultra</intervention_name>
    <description>Comparator without lidocaine</description>
    <arm_group_label>Revanesse Ultra+</arm_group_label>
    <other_name>Revanesse Versa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following criteria to be eligible for the study:&#xD;
&#xD;
               1. Men or women 22 years of age or older seeking augmentation therapy for correction&#xD;
                  of bilateral nasolabial folds.&#xD;
&#xD;
               2. Two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating&#xD;
                  Scale Score (WSRS) of 3 or 4 that may be corrected with an injectable dermal&#xD;
                  filler. The NLFs should be symmetrical, i.e., WSRS scores at NLFs on both sides&#xD;
                  should be the same (both Moderate [3] or both Severe [4]).&#xD;
&#xD;
               3. If female and of childbearing potential, a negative urine pregnancy test and&#xD;
                  agree to use adequate contraception. Female subjects of childbearing potential&#xD;
                  (excluding women who are surgically sterilized or postmenopausal for at least 2&#xD;
                  years) must have a negative urine pregnancy test and must be willing to use a&#xD;
                  medically accepted method of contraception during the study. The following are&#xD;
                  considered acceptable methods of birth control for the purpose of this study:&#xD;
                  oral contraceptives, contraceptive patches, contraceptive implant, vaginal&#xD;
                  contraceptive, double barrier methods (e.g., condom and spermicide),&#xD;
                  contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD&#xD;
                  (Mirena®), and abstinence with a documented second acceptable method of birth&#xD;
                  control if the subject becomes sexually active. Subjects entering the study who&#xD;
                  are on hormonal contraceptives must have been on the method for at least 90 days&#xD;
                  prior to the study and continue the method for the duration of the study.&#xD;
                  Subjects who had used hormonal contraception and stopped must have stopped no&#xD;
                  less than 90 days prior to Visit 1/Day 1.&#xD;
&#xD;
               4. Ability to understand and comply with the requirements of the study.&#xD;
&#xD;
               5. Willingness and ability to provide written informed consent. 6. Agree to refrain&#xD;
                  from seeking other treatment for this condition during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who meet any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Wrinkle Severity Rating Scale Score of ≤ 2 on the right or left nasolabial fold.&#xD;
&#xD;
          2. Women who are pregnant or lactating.&#xD;
&#xD;
          3. Received prior dermabrasion, facelift, or Botox below the orbital rim, or had&#xD;
             undergone procedures based on active dermal response (e.g., laser or chemical peeling&#xD;
             procedures) within 6 months (180 days) prior to study entry.&#xD;
&#xD;
          4. Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic&#xD;
             facial surgical therapy within 9 months prior to study entry.&#xD;
&#xD;
          5. Has ever received semi-permanent fillers anywhere in the face or neck, or is planning&#xD;
             to be implanted with these products during the study.&#xD;
&#xD;
          6. Has a permanent implant placed in the NLF area.&#xD;
&#xD;
          7. Evidence of scar-related disease or delayed healing activity within the past 1 year.&#xD;
&#xD;
          8. Scars at the intended treatment sites.&#xD;
&#xD;
          9. History of keloid formation or hypertrophic scars.&#xD;
&#xD;
         10. Any infection or unhealed wound on the face.&#xD;
&#xD;
         11. Allergic history including anaphylaxis, multiple severe allergies, atopy, or allergies&#xD;
             to natural rubber latex, lidocaine or any amide-based anesthetic, hyaluronic acid&#xD;
             products, or Streptococcal proteins or have plans to undergo desensitization therapy&#xD;
             during the term of the study.&#xD;
&#xD;
         12. Aspirin or nonsteroidal anti-inflammatory drugs within 1 week (7 days) prior to&#xD;
             treatment.&#xD;
&#xD;
         13. Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding&#xD;
             disorders, coagulation defects or connective tissue disorders.&#xD;
&#xD;
         14. Over-the-counter (OTC) wrinkle products or prescription wrinkle treatments within 4&#xD;
             weeks (28 days) prior to treatment and throughout the study.&#xD;
&#xD;
         15. Immunocompromised or immunosuppressed.&#xD;
&#xD;
         16. Clinically significant organic disease including clinically significant&#xD;
             cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical&#xD;
             condition, serious intercurrent illness, or extenuating circumstance that, in the&#xD;
             opinion of the investigator, preclude participation in the trial.&#xD;
&#xD;
         17. Received any investigational product within 30 days of signing the Informed Consent&#xD;
             Form.&#xD;
&#xD;
         18. Facial tattoo that may interfere with diagnosis.&#xD;
&#xD;
         19. Systemic (oral/injectable) corticosteroids or immunosuppressive medications within 30&#xD;
             days prior to treatment and topical steroids on the face within 14 days prior to&#xD;
             treatment start and throughout the study.&#xD;
&#xD;
         20. Acne and/or other inflammatory diseases of the skin.&#xD;
&#xD;
         21. Acute or chronic skin disease, inflammation or related conditions, cancerous or&#xD;
             precancerous lesions on or near the injection sites.-&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael H. Gold, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tennessee Clinical Research, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <results_first_submitted>October 1, 2018</results_first_submitted>
  <results_first_submitted_qc>March 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 11, 2019</results_first_posted>
  <disposition_first_submitted>August 28, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>September 13, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 18, 2018</disposition_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02991040/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02991040/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was undertaken between August 24 2016 and June 21 2017. Subjects that were randomized, there were 100 intent-to-treat (ITT), 95 modified intent-to-treat (mITT), 75 per-protocol (PP) subjects. Of the subjects randomized there were 17 subjects in the rollover subset (17 ITT, 12 mITT, and 12 PP subjects).&#xD;
96 Subjects completed the study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Revanesse Ultra+</title>
          <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>There were 100 subjects randomized, in accordance with the inclusion / exclusion criteria, who were men or women at least 22 years of age with two fully visible bilateral nasolabial folds each with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe)</population>
      <group_list>
        <group group_id="B1">
          <title>Revanesse Ultra+</title>
          <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </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="NA">exclusion criteria</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.0" lower_limit="30" upper_limit="83"/>
                  </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="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </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>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="1"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                  </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="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection</title>
        <description>Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome</description>
        <time_frame>at injection Time 0</time_frame>
        <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Revanesse Ultra</title>
            <description>Revanesse Ultra (without lidocaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection</title>
          <description>Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome</description>
          <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
          <units>VAS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" spread="24.51"/>
                    <measurement group_id="O2" value="39.4" spread="25.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection</title>
        <description>Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.</description>
        <time_frame>15, 30, 45, and 60 minutes post injection and at 2 weeks post injection</time_frame>
        <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Revanesse Ultra</title>
            <description>Revanesse Ultra (without lidocaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection</title>
          <description>Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.</description>
          <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
          <units>VAS score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52" spread="14.83"/>
                    <measurement group_id="O2" value="15.26" spread="18.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.72" spread="9.10"/>
                    <measurement group_id="O2" value="7.46" spread="11.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.66" spread="6.61"/>
                    <measurement group_id="O2" value="4.21" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="6.39"/>
                    <measurement group_id="O2" value="2.86" spread="7.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks post injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="1.07"/>
                    <measurement group_id="O2" value="0.25" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wrinkle Severity Rating Score (WSRS)</title>
        <description>The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.</description>
        <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
        <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Wrinkle Severity Rating Score (WSRS)</title>
          <description>The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.</description>
          <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.</population>
          <units>Wrinkle Severity Rating 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="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2/Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3/ Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4/Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5/Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Aesthetic Improvement</title>
        <description>Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.</description>
        <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
        <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Aesthetic Improvement</title>
          <description>Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.</description>
          <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.</population>
          <units>score 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="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2/Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread=".35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3/Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4/Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5/Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Investigator Global Aesthetic Improvement</title>
        <description>Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.</description>
        <time_frame>Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
        <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Investigator Global Aesthetic Improvement</title>
          <description>Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.</description>
          <population>mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face</population>
          <units>score 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="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2/Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3/Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4/Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5/Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events</title>
        <description>study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)</description>
        <time_frame>at injection, Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)</time_frame>
        <population>ITT (safety population): All randomized subjects who received study product</population>
        <group_list>
          <group group_id="O1">
            <title>Revanesse Ultra+</title>
            <description>Revanesse Ultra+ (with lidocaine)&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
          </group>
          <group group_id="O2">
            <title>Revanesse Ultra</title>
            <description>Revanesse Ultra (without lidocaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events</title>
          <description>study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)</description>
          <population>ITT (safety population): All randomized subjects who received study product</population>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Revanesse Ultra+</title>
          <description>Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine&#xD;
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)&#xD;
Revanesse Ultra: Comparator without lidocaine</description>
        </group>
        <group group_id="E2">
          <title>Revanesse Ultra</title>
          <description>Revanesse Ultra (without lidocaine)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening Right Knee Pain (arthralgia)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="53" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Bruising</sub_title>
                <counts group_id="E1" events="37" subjects_affected="32" subjects_at_risk="100"/>
                <counts group_id="E2" events="39" subjects_affected="31" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E2" events="28" subjects_affected="21" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="100"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="100"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="100"/>
              </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>Mr. Ario Khoshbin</name_or_title>
      <organization>Prollenium Medical Technologies Inc.</organization>
      <phone>+1 (905) 508-1469</phone>
      <email>ario@prollenium.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/NCT02991040
org study id: SYM2016-02
nct id: NCT02991040
lead sponsor: 
has dmc: Yes
is fda regulated device: Yes
A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy
      of Revanesse® Ultra + (with Lidocaine) versus Revanesse® Ultra for the Correction of
      Nasolabial Folds to compare the safety and efficacy profiles of Revanesse® Ultra + (with
      lidocaine, hereafter referred to as Revanesse Ultra +) to Revanesse Ultra for subjects
      undergoing correction of nasolabial folds (NLFs)
This is a randomized, multicenter, double-blind, split-face study in subjects seeking
      nasolabial fold correction. Subjects will be treated with Revanesse Ultra + in the NLF on one
      side of the face and Revanesse Ultra in the NLF on the other side of the face. The side of
      the face for each study product will be randomly assigned. The investigator and the subject
      will be blinded to the treatment; injections of the study product will be performed by an
      unblinded injecting investigator.

      At each visit, investigator and subject evaluations of the treated areas will be performed
      and recorded
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects were treated with Revanesse Ultra in the NLF on one side of the face and Revanesse Ultra+ in the NLF on the other side of the face. The side of the face for each study product was randomly assigned.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The side of the face for each product was randomly assigned. The investigator performing the evaluations and the subject were blinded to the treatment; injections of the study product were performed by an unblinded injecting investigator.
measure: Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection
time frame: at injection Time 0
description: Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
measure: Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
time frame: 15, 30, 45, and 60 minutes post injection and at 2 weeks post injection
description: Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.
measure: Wrinkle Severity Rating Score (WSRS)
time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
description: The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
measure: Patient Global Aesthetic Improvement
time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
description: Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.
measure: Investigator Global Aesthetic Improvement
time frame: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
description: Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.
measure: Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events
time frame: at injection, Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)
description: study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)
arm group label: Revanesse Ultra+
arm group type: Experimental
description: Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine
intervention type: Device
intervention name: Revanesse Ultra+ (with lidocaine)
description: Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
arm group label: Revanesse Ultra+
other name: Revanesse Versa+
intervention type: Device
intervention name: Revanesse Ultra
description: Comparator without lidocaine
arm group label: Revanesse Ultra+
other name: Revanesse Versa
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael H. Gold, MD
role: Principal Investigator
affiliation: Tennessee Clinical Research, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lidocaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 