<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/NCT03831477</url>
  </required_header>
  <id_info>
    <org_study_id>VI1218</org_study_id>
    <nct_id>NCT03831477</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles</brief_title>
  <official_title>Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Venus Concept</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Venus Concept</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single centre, evaluator-blind study of the safety and performance of fractional&#xD;
      radiofrequency (RF) for the treatment and reduction of facial wrinkles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate 15 subjects requesting treatment of their facial wrinkles. The study&#xD;
      will involve three treatments on both sides of the face with 3-5 week intervals between each&#xD;
      treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis&#xD;
      will be performed on all subjects who receive at least one treatment. An additional&#xD;
      histological analysis will be conducted including up to 12 of the participating subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">August 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, single centre, evaluator-blind study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Evaluator blinded assessment of photographs</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline</measure>
    <time_frame>12 Weeks Post Final Treatment</time_frame>
    <description>Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>12 Weeks Post-Final Treatment</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being &quot;very unsatisfied&quot; and 4 &quot;very satisfied&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - Visual Analog Scale for Pain</measure>
    <time_frame>An average of all 3 treatments</time_frame>
    <description>Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - 5 Point Scale for Treatment Tolerability</measure>
    <time_frame>An average of all 3 treatments</time_frame>
    <description>Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being &quot;very tolerable&quot; and 0 &quot;very intolerable&quot;. VAS was measured following each of the 3 treatments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Rhytides</condition>
  <condition>Wrinkle</condition>
  <arm_group>
    <arm_group_label>80 pin applicator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>160 pin applicator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Venus Viva</intervention_name>
    <description>The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.</description>
    <arm_group_label>160 pin applicator</arm_group_label>
    <arm_group_label>80 pin applicator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, male or female subjects over 21 years of age who are seeking treatment and&#xD;
             reduction of their facial wrinkles.&#xD;
&#xD;
          2. Able to read, understand and voluntarily provide written Informed Consent.&#xD;
&#xD;
          3. Able and willing to comply with the treatment/follow-up schedule and requirements.&#xD;
&#xD;
          4. Women of child-bearing age are required to be using a reliable method of birth control&#xD;
             at least 3 months prior to study enrollment and for the duration of the study and have&#xD;
             a negative Urine Pregnancy test at baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implantable defibrillators, cardiac pacemakers, and other metal implants&#xD;
&#xD;
          2. Subjects with any implantable metal device in the treatment area&#xD;
&#xD;
          3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere&#xD;
             in the body (e.g. cochlear implant).&#xD;
&#xD;
          4. Permanent implant in the treated area, such as metal plates and screws, or an injected&#xD;
             chemical substance.&#xD;
&#xD;
          5. Current or history of any kind of cancer, or pre-malignant moles.&#xD;
&#xD;
          6. Severe concurrent conditions, such as cardiac disorders.&#xD;
&#xD;
          7. Pregnancy or intending to become pregnant during the study and nursing.&#xD;
&#xD;
          8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use&#xD;
             of immunosuppressive medications.&#xD;
&#xD;
          9. History of diseases stimulated by heat, such as recurrent herpes simplex in the&#xD;
             treatment area; may be enrolled only after a prophylactic regime has been followed for&#xD;
             2 weeks or longer prior to enrollment, or according to Investigator's discretion.&#xD;
&#xD;
         10. Poorly controlled endocrine disorders, such as diabetes.&#xD;
&#xD;
         11. Any active condition in the treatment area, such as sores, psoriasis, eczema, and&#xD;
             rash.&#xD;
&#xD;
         12. History of skin disorders, such as keloids, abnormal wound healing, as well as very&#xD;
             dry and fragile skin.&#xD;
&#xD;
         13. History of bleeding coagulopathies, or use of anticoagulants (excluding daily&#xD;
             aspirin).&#xD;
&#xD;
         14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last&#xD;
             three months, if face is treated.&#xD;
&#xD;
         15. Use of isotretinoin (Accutane®) or other systemic retinoids within six months or&#xD;
             topical retinoids within three months prior to treatment; or as per physician's&#xD;
             discretion.&#xD;
&#xD;
         16. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing&#xD;
             agents) one week before and after each treatment session.&#xD;
&#xD;
         17. Any surgical procedure in the treatment area within the last six months or before&#xD;
             complete healing.&#xD;
&#xD;
         18. Treating over tattoo or permanent makeup.&#xD;
&#xD;
         19. Excessively tanned skin from sun, tanning beds or tanning creams within the last two&#xD;
             weeks.&#xD;
&#xD;
         20. As per the practitioner's discretion, refrain from treating any condition which might&#xD;
             make it unsafe for the patient.&#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>Matthew Gronski</last_name>
    <role>Study Director</role>
    <affiliation>Venus Concept</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sadick Research Group</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>July 27, 2023</results_first_submitted>
  <results_first_submitted_qc>August 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 6, 2023</results_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fractional radiofrequency</keyword>
  <keyword>fractional RF</keyword>
  <keyword>wrinkles</keyword>
  <keyword>facial wrinkles</keyword>
  <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>October 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03831477/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Viva Treatment</title>
          <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Viva Treatment</title>
          <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="56.7" spread="10.2"/>
                  </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="15"/>
                  </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>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="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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="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="15"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline</title>
        <description>Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.</description>
        <time_frame>12 Weeks Post Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viva Treatment</title>
            <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline</title>
          <description>Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Sides of the face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sides of the face</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction</title>
        <description>Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being &quot;very unsatisfied&quot; and 4 &quot;very satisfied&quot;.</description>
        <time_frame>12 Weeks Post-Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viva Treatment</title>
            <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being &quot;very unsatisfied&quot; and 4 &quot;very satisfied&quot;.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Scale - Visual Analog Scale for Pain</title>
        <description>Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments.</description>
        <time_frame>An average of all 3 treatments</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viva Treatment</title>
            <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Scale - Visual Analog Scale for Pain</title>
          <description>Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments.</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Scale - 5 Point Scale for Treatment Tolerability</title>
        <description>Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being &quot;very tolerable&quot; and 0 &quot;very intolerable&quot;. VAS was measured following each of the 3 treatments.</description>
        <time_frame>An average of all 3 treatments</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Viva Treatment</title>
            <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Scale - 5 Point Scale for Treatment Tolerability</title>
          <description>Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being &quot;very tolerable&quot; and 0 &quot;very intolerable&quot;. VAS was measured following each of the 3 treatments.</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="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.55" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Viva Treatment</title>
          <description>Venus Viva: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator. Subjects received 3 treatments on both sides of the face with 3-5 week intervals between each treatment</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="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
              </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 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>Director of Clinical Affairs</name_or_title>
      <organization>Venus Concept</organization>
      <phone>888-907-0115</phone>
      <email>mgronski@venusconcept.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/NCT03831477
org study id: VI1218
nct id: NCT03831477
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Prospective, single centre, evaluator-blind study of the safety and performance of fractional
      radiofrequency (RF) for the treatment and reduction of facial wrinkles.
The study will evaluate 15 subjects requesting treatment of their facial wrinkles. The study
      will involve three treatments on both sides of the face with 3-5 week intervals between each
      treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis
      will be performed on all subjects who receive at least one treatment. An additional
      histological analysis will be conducted including up to 12 of the participating subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Prospective, single centre, evaluator-blind study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Evaluator blinded assessment of photographs
measure: Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline
time frame: 12 Weeks Post Final Treatment
description: Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.
measure: Subject Satisfaction
time frame: 12 Weeks Post-Final Treatment
description: Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale at 12 weeks post-treatment with 0 being "very unsatisfied" and 4 "very satisfied".
measure: Subject Scale - Visual Analog Scale for Pain
time frame: An average of all 3 treatments
description: Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being maximal pain. VAS was measured following each of the 3 treatments.
measure: Subject Scale - 5 Point Scale for Treatment Tolerability
time frame: An average of all 3 treatments
description: Subject's assessment of treatment tolerability as measured by a 5-point scale with 4 being "very tolerable" and 0 "very intolerable". VAS was measured following each of the 3 treatments.
arm group label: 80 pin applicator
arm group type: Experimental
arm group label: 160 pin applicator
arm group type: Active Comparator
intervention type: Device
intervention name: Venus Viva
description: The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
arm group label: 160 pin applicator
arm group label: 80 pin applicator
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Gronski
role: Study Director
affiliation: Venus Concept
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 