<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/NCT03776461</url>
  </required_header>
  <id_info>
    <org_study_id>VI0918</org_study_id>
    <nct_id>NCT03776461</nct_id>
  </id_info>
  <brief_title>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 50 treatment sites in subjects requesting treatment of their facial&#xD;
      wrinkles. The study will involve three treatments on both sides of the face with 3-5 week&#xD;
      intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their&#xD;
      last treatment. Analysis will be performed on all subjects who receive at least one treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">June 18, 2021</completion_date>
  <primary_completion_date type="Actual">June 18, 2021</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>Subject Satisfaction</measure>
    <time_frame>12 Weeks Post Last Treatment (Around Week 20)</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>6 Weeks Post Last Treatment (Around Week 14)</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - Visual Analog Scale for Pain</measure>
    <time_frame>Post Treatment at the Baseline, 4 Week and 8 Week treatment visits</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 pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.</measure>
    <time_frame>Post Treatment at the Baseline, 4 Week and 8 Week treatment visits</time_frame>
    <description>Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</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>
    <description>3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>160 pin applicator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks.</description>
  </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 retinoids within six months prior to&#xD;
             treatment or as per physician's 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>Scripps Clinic Carmel Valley</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92130</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>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>June 21, 2023</results_first_submitted>
  <results_first_submitted_qc>July 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 4, 2023</results_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fractional radiofrequency</keyword>
  <keyword>fractional RF</keyword>
  <keyword>facial wrinkles</keyword>
  <keyword>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 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03776461/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>80-pin Applicator</title>
          <description>3 treatments with either the Venus Viva 80-pin or 160-tip applicator at 0, 4, and 8 weeks.&#xD;
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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</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.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </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="62.4" spread="7.7"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </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="25"/>
                  </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>Fitzpatrick Skin Type</title>
          <description>The Fitzpatrick scale is a numerical classification schema for human skin color. Higher numbers mean darker skin.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subject Satisfaction</title>
        <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
        <time_frame>12 Weeks Post Last Treatment (Around Week 20)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 20.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
          <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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Subject Satisfaction</title>
        <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
        <time_frame>6 Weeks Post Last Treatment (Around Week 14)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>3 treatments with Viva at 0, 4, and 8 weeks. Assessment at Week 14.&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.</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="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.8"/>
                  </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 pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.</description>
        <time_frame>Post Treatment at the Baseline, 4 Week and 8 Week treatment visits</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>3 treatments with Viva at 0, 4, and 8 weeks. Assessment immediately post-treatment.&#xD;
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.</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 pain as bad as it can be. For each subject, the mean VAS score was taken from 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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.</title>
        <description>Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.</description>
        <time_frame>Post Treatment at the Baseline, 4 Week and 8 Week treatment visits</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Subjects</title>
            <description>3 treatments with Viva at 0, 4, and 8 weeks. Assessment immediately post-treatment&#xD;
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.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.</title>
          <description>Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.8"/>
                  </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>All Participants</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.</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="5" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cold Sore</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </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/NCT03776461
org study id: VI0918
nct id: NCT03776461
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 50 treatment sites in 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
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: Subject Satisfaction
time frame: 12 Weeks Post Last Treatment (Around Week 20)
description: Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
measure: Subject Satisfaction
time frame: 6 Weeks Post Last Treatment (Around Week 14)
description: Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment.
measure: Subject Scale - Visual Analog Scale for Pain
time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
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 pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments.
measure: Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable.
time frame: Post Treatment at the Baseline, 4 Week and 8 Week treatment visits
description: Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken.
arm group label: 80-pin applicator
arm group type: Experimental
description: 3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks.
arm group label: 160 pin applicator
arm group type: Active Comparator
description: 3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks.
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: 