<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/NCT03285581</url>
  </required_header>
  <id_info>
    <org_study_id>C-17-TS14</org_study_id>
    <nct_id>NCT03285581</nct_id>
  </id_info>
  <brief_title>Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction</brief_title>
  <official_title>Open-label, Prospective, Multicenter Pivotal Study of the Cutera truSculpt™ Radiofrequency Device for Wrinkle Reduction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutera Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cutera Inc.</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pivotal investigation is to evaluate the safety and efficacy of the&#xD;
      Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or&#xD;
      female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and&#xD;
      improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™&#xD;
      radiofrequency (RF) device. Subjects will return to the site after study treatments have been&#xD;
      delivered 12 weeks post-final treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 20, 2018</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>
  </study_design_info>
  <primary_outcome>
    <measure>Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)</measure>
    <time_frame>12 weeks post-final treatment</time_frame>
    <description>GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Wrinkle Reduction</condition>
  <arm_group>
    <arm_group_label>truSculpt RF</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will receive RF treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>truSculpt RF</intervention_name>
    <description>Subjects will receive RF treatments</description>
    <arm_group_label>truSculpt RF</arm_group_label>
    <other_name>Device: Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be able to understand and provide written informed consent and release of health&#xD;
             information&#xD;
&#xD;
          2. Male or Female, 25 to 65 years of age (inclusive)&#xD;
&#xD;
          3. Fitzpatrick Skin Type I - VI (Appendix 4)&#xD;
&#xD;
          4. Has visible wrinkles or skin laxity in the treatment area&#xD;
&#xD;
          5. On the Fitzpatrick Classification Wrinkle Classification System subject has a&#xD;
             pre-treatment score of 4-9 (inclusive) (Appendix 5)&#xD;
&#xD;
          6. No use of tobacco products for at least 6 months and willing to refrain from use for&#xD;
             the duration of the study&#xD;
&#xD;
          7. Subject must agree to not undergo any other cosmetic procedure(s) area, or start&#xD;
             topical retinol products in the treatment area during the study period&#xD;
&#xD;
          8. Subject must be willing to adhere to the follow-up schedule and study instructions&#xD;
&#xD;
          9. Subject must be willing to adhere to the same diet and/or exercise routine throughout&#xD;
             the study, and agree to maintain the same weight throughout the study, within 10% of&#xD;
             baseline weight measurement&#xD;
&#xD;
         10. Willing to have digital photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentations, educational, and/or marketing purposes&#xD;
&#xD;
         11. For female subjects: not pregnant or lactating and is either post-menopausal,&#xD;
             surgically sterilized, or using a medically acceptable form of birth control at least&#xD;
             3 months prior to enrollment and during the entire course of the study, and no plans&#xD;
             to become pregnant -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical trial of a drug or another device in the target area&#xD;
             within 3 months of study participation, or during the study.&#xD;
&#xD;
          2. Any type of prior cosmetic treatment to the target area within 12 months of study&#xD;
             participation e.g., radiofrequency, cryolipolysis, deoxycholate injection, or&#xD;
             light-based treatments&#xD;
&#xD;
          3. Prior injection of botulinum toxin, collagen, hyaluronic acid filler, or other dermal&#xD;
             filler, and medium-depth to deep chemical peels, to the treatment area within 6 months&#xD;
             of study participation&#xD;
&#xD;
          4. History of systemic steroid use within 3 months; history of topical steroid use in the&#xD;
             target area within 2 months&#xD;
&#xD;
          5. History of systemic retinoid (isotretinoin) and therapeutic dose of Vitamin A within 6&#xD;
             months of study participation&#xD;
&#xD;
          6. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve&#xD;
             stimulator implant, cochlear implant or any other electronically, magnetically or&#xD;
             mechanically activated implant&#xD;
&#xD;
          7. Has metal implant(s) within the body that are local to the treatment area, such as&#xD;
             surgical clips, plates and screws (metal tooth fillings or crowns will not exclude&#xD;
             subject participation), or has , artificial heart valves or artificial joints&#xD;
&#xD;
          8. Clinically significant concurrent illness, such as diabetes mellitus, cardiovascular&#xD;
             disease, peripheral vascular disease or pertinent neurological disorders that in the&#xD;
             opinion of the Investigator will confound participation in the study&#xD;
&#xD;
          9. Diagnosed or documented immune system disorders&#xD;
&#xD;
         10. History of any disease or condition that could impair wound healing&#xD;
&#xD;
         11. History of diseases stimulated by heat, such as recurrent herpes zoster in the&#xD;
             treatment area, unless treatment is conducted following a prophylactic regimen&#xD;
&#xD;
         12. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing&#xD;
&#xD;
         13. Infection, dermatitis, rash or other skin abnormality in the target area&#xD;
&#xD;
         14. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or&#xD;
             history of treatment in the target area within 3 months of study participation&#xD;
&#xD;
         15. Anticipated or planned need for surgery or hospitalization during the duration of the&#xD;
             study&#xD;
&#xD;
         16. Pregnant, nursing, or planning a pregnancy during the trial; or is a woman of child&#xD;
             bearing potential but is not willing to use an acceptable method of contraception as&#xD;
             determined by the Investigator&#xD;
&#xD;
         17. As per the Investigator's discretion, any physical or psychological condition which&#xD;
             might make it unsafe for the subject to participate in this study -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Ronan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cutera Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Friedmann, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Westlake Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cutera Research Center</name>
      <address>
        <city>Brisbane</city>
        <state>California</state>
        <zip>94005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westlake Dermatology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</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>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>August 22, 2023</results_first_submitted>
  <results_first_submitted_qc>August 22, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>August 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03285581/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm-1</title>
          <description>Subject(s) will receive RF treatments</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>truSculpt RF</title>
          <description>Subject will receive RF treatments</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="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="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="38"/>
                  </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>Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)</title>
        <description>GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes</description>
        <time_frame>12 weeks post-final treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>truSculpt RF</title>
            <description>Subject will receive RF treatments</description>
          </group>
        </group_list>
        <measure>
          <title>Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)</title>
          <description>GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes</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="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks post final treatment, up to 7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>truSculpt RF</title>
          <description>Subjects will receive RF treatments</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="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
              </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="39" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="39"/>
              </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>Margot Doucette</name_or_title>
      <organization>Cutera</organization>
      <phone>415-656-9612</phone>
      <email>mdoucette@cutera.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/NCT03285581
org study id: C-17-TS14
nct id: NCT03285581
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the
      Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.
This is an Open-label, Prospective, Multicenter Pivotal Study of approximately 40 male or
      female subjects, age 25 to 65 years who desire RF treatment for wrinkle reduction and
      improvement in skin quality. Subjects will receive RF treatments with the Cutera truSculpt™
      radiofrequency (RF) device. Subjects will return to the site after study treatments have been
      delivered 12 weeks post-final treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Principal Investigator's Assessment of Improvement at 12 Weeks Post-final Treatment (Physician's Global Assessment of Improvement=GAIS)
time frame: 12 weeks post-final treatment
description: GAIS: 4=Very Significant Improvement, 3=Significant Improvement, 2=Moderate Improvement, 1=Mild Improvement, 0=No Change Higher scores indicate better outcomes
arm group label: truSculpt RF
arm group type: Other
description: Subjects will receive RF treatments
intervention type: Device
intervention name: truSculpt RF
description: Subjects will receive RF treatments
arm group label: truSculpt RF
other name: Device: Treatment
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Ronan, M.D.
role: Principal Investigator
affiliation: Cutera Research Center
last name: Daniel Friedmann, M.D.
role: Principal Investigator
affiliation: Westlake Dermatology
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 