<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/NCT03821324</url>
  </required_header>
  <id_info>
    <org_study_id>VI1118</org_study_id>
    <nct_id>NCT03821324</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Fractional Radiofrequency for the Treatment 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;
      the progress of 15 subjects requesting treatment of acne scarring. The study will involve&#xD;
      three treatments on both sides of the face with 3-5 week intervals between each treatment.&#xD;
      Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be&#xD;
      performed on all subjects who receive at least one treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">October 3, 2019</completion_date>
  <primary_completion_date type="Actual">October 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Acne Scar Improvement</measure>
    <time_frame>12 weeks post-final treatment (approximately Week 20)</time_frame>
    <description>Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction</measure>
    <time_frame>12 weeks post-final treatment (approximately Week 20)</time_frame>
    <description>Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Scale - Visual Analog Scale for Pain</measure>
    <time_frame>Immediately post-treatment at each treatment (average of all 3 treatments)</time_frame>
    <description>Subjects' 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. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Tolerability</measure>
    <time_frame>Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments)</time_frame>
    <description>Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Acne Scars</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Device: Venus Viva</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Venus Viva</intervention_name>
    <description>The Venus Viva™ fractional RF device 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.</description>
    <arm_group_label>Intervention</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 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 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>March 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</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>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</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 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03821324/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>6 Weeks After Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>12 Weeks After Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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.</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="44.5" spread="11.3"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>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="3"/>
                  </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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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>Acne Scar Improvement</title>
        <description>Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).</description>
        <time_frame>12 weeks post-final treatment (approximately Week 20)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>12-weeks After Last Treatment</title>
            <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Acne Scar Improvement</title>
          <description>Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>Sides of face</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Sides of face</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="0.26" 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 (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment.</description>
        <time_frame>12 weeks post-final treatment (approximately Week 20)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>12-weeks After Final Treatment</title>
            <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction</title>
          <description>Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale (ranging from 0 Very Unsatisfied to 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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Scale - Visual Analog Scale for Pain</title>
        <description>Subjects' 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. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.</description>
        <time_frame>Immediately post-treatment at each treatment (average of all 3 treatments)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Scale - Visual Analog Scale for Pain</title>
          <description>Subjects' 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. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.09" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Tolerability</title>
        <description>Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).</description>
        <time_frame>Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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 sides 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>Treatment Tolerability</title>
          <description>Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" spread="0.45"/>
                  </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>Intervention</title>
          <description>Device: Venus Viva&#xD;
Venus Viva: The Venus Viva™ fractional RF device 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 sides 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"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="3" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Head Cold</sub_title>
                <description>Mild, Not-related to treatment</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Shingles</sub_title>
                <description>Moderate, Not related to treatment</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperpigmentation</sub_title>
                <description>Mild, Probably related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </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/NCT03821324
org study id: VI1118
nct id: NCT03821324
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
      the progress of 15 subjects requesting treatment of 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: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Blinded evaluation of photographs taken at baseline and at 6, 12 weeks post final treatment by independent evaluators.
measure: Acne Scar Improvement
time frame: 12 weeks post-final treatment (approximately Week 20)
description: Change in acne scarring at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators using photographs a 7-point Global Aesthetic Improvement Scale (GAIS) (ranges from -3 Very Much Worse to +3 Very Much Improved).
measure: Subject Satisfaction
time frame: 12 weeks post-final treatment (approximately Week 20)
description: Subjects' assessment of satisfaction with the treatment using a 5-point Subject Satisfaction Scale (ranging from 0 Very Unsatisfied to 4 Very Satisfied) at 6 weeks and 12 weeks post-treatment.
measure: Subject Scale - Visual Analog Scale for Pain
time frame: Immediately post-treatment at each treatment (average of all 3 treatments)
description: Subjects' 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. Each subject was asked to rate their pain after each of the 3 treatments. The result is the mean of each subject's mean VAS score.
measure: Treatment Tolerability
time frame: Immediately post-treatment at each treatment (mean of the tolerability scores following each of the 3 treatments)
description: Subjects' assessment of treatment tolerability as measured by a 5-point scale ranging from 0 (Very Intolerable) to 4 (Very Tolerable).
arm group label: Intervention
arm group type: Other
description: Device: Venus Viva
intervention type: Device
intervention name: Venus Viva
description: The Venus Viva™ fractional RF device 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: Intervention
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: 