<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/NCT03767153</url>
  </required_header>
  <id_info>
    <org_study_id>VI1018</org_study_id>
    <nct_id>NCT03767153</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Fractional Radiofrequency for the Treatment of Acne Scarring</brief_title>
  <official_title>Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring</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>
  </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 acne scarring. The study will evaluate&#xD;
      50 treatment sites in subjects requesting treatment of their acne scarring. The study will&#xD;
      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.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">December 22, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.</measure>
    <time_frame>12 Weeks Post-Final Treatment</time_frame>
    <description>Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).&#xD;
The Global Aesthetic Improvement Scale is a seven-grade subjective test.&#xD;
Three independent evaluators evaluated before and after photographs and graded them for change.&#xD;
Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>6 Weeks and 12 Weeks Post- Final Treatment</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 Weeks and 12 weeks post-treatment.&#xD;
The Subject Satisfaction Scale is a five-grade subjective test.&#xD;
Participant were asked their satisfaction level post treatment.&#xD;
Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - Visual Analog Scale for Pain</measure>
    <time_frame>12 Weeks Post-Final Treatment</time_frame>
    <description>Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS).&#xD;
The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be).&#xD;
Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events [Safety]</measure>
    <time_frame>Up to 12 Weeks Post-Final Treatment</time_frame>
    <description>Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - 5 Point Scale for Treatment Tolerability</measure>
    <time_frame>12 Weeks Post-Final Treatment</time_frame>
    <description>Subject's assessment of treatment tolerability as measured by a 5 point scale.&#xD;
Participant were asked their tolerability level post treatment.&#xD;
Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Acne Scars</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™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</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 22 years of age or over who are seeking treatment and&#xD;
             reduction of their facial acne scarring.&#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>Leavitt Medical Associates of Florida d/b/a Ameriderm Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <results_first_submitted>February 3, 2021</results_first_submitted>
  <results_first_submitted_qc>February 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2021</results_first_posted>
  <last_update_submitted>February 26, 2021</last_update_submitted>
  <last_update_submitted_qc>February 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne scarring</keyword>
  <keyword>acne scar</keyword>
  <keyword>fractional radiofrequency</keyword>
  <keyword>fractional RF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_browse>
  <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 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03767153/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>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
        </group>
        <group group_id="P2">
          <title>160 Pin Applicator</title>
          <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>80 Pin Applicator</title>
          <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
        </group>
        <group group_id="B2">
          <title>160 Pin Applicator</title>
          <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" 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="46.2" spread="13.5"/>
                    <measurement group_id="B2" value="45.0" spread="10.1"/>
                    <measurement group_id="B3" value="45.7" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <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="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.</title>
        <description>Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).&#xD;
The Global Aesthetic Improvement Scale is a seven-grade subjective test.&#xD;
Three independent evaluators evaluated before and after photographs and graded them for change.&#xD;
Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).</description>
        <time_frame>12 Weeks Post-Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>80 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
          <group group_id="O2">
            <title>160 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.</title>
          <description>Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).&#xD;
The Global Aesthetic Improvement Scale is a seven-grade subjective test.&#xD;
Three independent evaluators evaluated before and after photographs and graded them for change.&#xD;
Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).</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="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="0.13"/>
                    <measurement group_id="O2" value="0.85" spread="0.13"/>
                  </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 6 Weeks and 12 weeks post-treatment.&#xD;
The Subject Satisfaction Scale is a five-grade subjective test.&#xD;
Participant were asked their satisfaction level post treatment.&#xD;
Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.</description>
        <time_frame>6 Weeks and 12 Weeks Post- Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>80 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
          <group group_id="O2">
            <title>160 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</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 6 Weeks and 12 weeks post-treatment.&#xD;
The Subject Satisfaction Scale is a five-grade subjective test.&#xD;
Participant were asked their satisfaction level post treatment.&#xD;
Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.</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="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="0.18"/>
                    <measurement group_id="O2" value="3.55" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="0.18"/>
                    <measurement group_id="O2" value="3.36" spread="0.24"/>
                  </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).&#xD;
The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be).&#xD;
Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).</description>
        <time_frame>12 Weeks Post-Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>80 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
          <group group_id="O2">
            <title>160 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</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).&#xD;
The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be).&#xD;
Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.26"/>
                    <measurement group_id="O2" value="2.05" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Related Adverse Events [Safety]</title>
        <description>Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.</description>
        <time_frame>Up to 12 Weeks Post-Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>80 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
          <group group_id="O2">
            <title>160 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Related Adverse Events [Safety]</title>
          <description>Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </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.&#xD;
Participant were asked their tolerability level post treatment.&#xD;
Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.</description>
        <time_frame>12 Weeks Post-Final Treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>80 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
          </group>
          <group group_id="O2">
            <title>160 Pin Applicator</title>
            <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</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.&#xD;
Participant were asked their tolerability level post treatment.&#xD;
Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.</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="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.36" spread="0.07"/>
                    <measurement group_id="O2" value="3.48" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>80 Pin Applicator</title>
          <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</description>
        </group>
        <group group_id="E2">
          <title>160 Pin Applicator</title>
          <description>Venus Viva: The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.&#xD;
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.</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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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>Clinical Research Manager</name_or_title>
      <organization>Venus Concept</organization>
      <phone>888-907-0115</phone>
      <email>rmays@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/NCT03767153
org study id: VI1018
nct id: NCT03767153
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Prospective, single centre, evaluator-blind study of the safety and performance of fractional
      radiofrequency (RF) for the treatment and reduction of acne scarring. The study will evaluate
      50 treatment sites in subjects requesting treatment of their acne scarring. 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
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded assessment of photographs taken at baseline and 6, 12 weeks post final treatment by independent evaluators.
measure: Overall Acne Scar Improvement Assessed by the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks.
time frame: 12 Weeks Post-Final Treatment
description: Evaluate the efficacy of overall facial acne scar improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).
The Global Aesthetic Improvement Scale is a seven-grade subjective test.
Three independent evaluators evaluated before and after photographs and graded them for change.
Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).
measure: Subject Satisfaction
time frame: 6 Weeks and 12 Weeks Post- Final Treatment
description: Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 6 Weeks and 12 weeks post-treatment.
The Subject Satisfaction Scale is a five-grade subjective test.
Participant were asked their satisfaction level post treatment.
Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
measure: Subject Scale - Visual Analog Scale for Pain
time frame: 12 Weeks Post-Final Treatment
description: Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS).
The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be).
Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain).
measure: Number of Participants With Treatment-Related Adverse Events [Safety]
time frame: Up to 12 Weeks Post-Final Treatment
description: Subjects experiencing a treatment-related adverse event (AE) by 12 weeks post-treatment.
measure: Subject Scale - 5 Point Scale for Treatment Tolerability
time frame: 12 Weeks Post-Final Treatment
description: Subject's assessment of treatment tolerability as measured by a 5 point scale.
Participant were asked their tolerability level post treatment.
Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
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™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
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
mesh term: Cicatrix
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 