<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/NCT01713933</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-114</org_study_id>
    <nct_id>NCT01713933</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ulthera® System for Treatment of the Brachia</brief_title>
  <official_title>Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Brachia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulthera, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merz North America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an evaluation of the Ulthera® System used to treat the upper arms for&#xD;
      improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm&#xD;
      treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study&#xD;
      photographs of the upper arms will be taken prior to treatment, immediately post-treatment,&#xD;
      and at each follow-up visit. Brachial volume and dermal thickness measurements will be&#xD;
      obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity</measure>
    <time_frame>Baseline to 90 days post-treatment</time_frame>
    <description>Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative Improvement in Skin Laxity</measure>
    <time_frame>Baseline to 90 days post-treatment</time_frame>
    <description>Assess change in brachial volume based on brachial tissue measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dermal Thickness</measure>
    <time_frame>Baseline to 90 days post-treatment</time_frame>
    <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dermal Thickness</measure>
    <time_frame>Baseline to180 days post-treatment</time_frame>
    <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Aesthetic Improvement</measure>
    <time_frame>Baseline to 60 days post-treatment</time_frame>
    <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Aesthetic Improvement</measure>
    <time_frame>Baseline to 90 days post-treatment</time_frame>
    <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Aesthetic Improvement</measure>
    <time_frame>Baseline to180 days post-treatment</time_frame>
    <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Baseline to 90 days post-treatment</time_frame>
    <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Baseline to 180 days post-treatment</time_frame>
    <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Brachial Ptosis</condition>
  <arm_group>
    <arm_group_label>Ultherapy™ treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera® System</intervention_name>
    <description>Focused ultrasound energy delivered below the surface of the skin.</description>
    <arm_group_label>Ultherapy™ treatment</arm_group_label>
    <other_name>Ultherapy™ treatment</other_name>
    <other_name>Ulthera, Inc.</other_name>
    <other_name>Ultrasound treatment for skin tightening</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 19 - 55 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Subjects who desire lift and tightening of the brachia and improvement in skin laxity.&#xD;
&#xD;
          -  Mild to moderate laxity of the upper arm.&#xD;
&#xD;
          -  Mild to moderate subcutaneous fat of the upper arm.&#xD;
&#xD;
          -  Mild crepiness of the skin of the upper arm.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             areas to be treated through the follow-up period.&#xD;
&#xD;
          -  Willingness and ability to comply with protocol requirements, including returning for&#xD;
             follow-up visits and abstaining from exclusionary procedures for the duration of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  Severe solar elastosis.&#xD;
&#xD;
          -  Excessive subcutaneous fat in the upper arm.&#xD;
&#xD;
          -  Excessive skin laxity in the upper arm.&#xD;
&#xD;
          -  Significant scarring in areas to be treated.&#xD;
&#xD;
          -  Significant open wounds or lesions in the treatment areas. 7. Severe or cystic acne in&#xD;
             the treatment areas.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gordon Sasaki, MD FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sasaki Advanced Aesthetic Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sasaki Advanced Aesthetic Medical Center</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>January 13, 2014</results_first_submitted>
  <results_first_submitted_qc>April 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 26, 2014</results_first_posted>
  <last_update_submitted>November 10, 2017</last_update_submitted>
  <last_update_submitted_qc>November 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ulthera® System</keyword>
  <keyword>Ultherapy™ treatment</keyword>
  <keyword>Ulthera, Inc.</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment opened 6/29/2011 and the last subject was treated 11/28/2011. Subjects were recruited from the site's patient database.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ultherapy® Treatment</title>
          <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Excluded from analysis as a BMI outlier</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Three subjects excluded due to subject withdrawal. One subject excluded from results analyses as an outlier, with a high Body Mass Index (BMI) and substantial weight gain during the study period.</population>
      <group_list>
        <group group_id="B1">
          <title>Ultherapy® Treatment</title>
          <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" lower_limit="25" upper_limit="57"/>
                  </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="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <description>Skin Type I = White;very fair,red or blonde hair blue eyes;freckles;Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes;Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily</description>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Type I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type VI</title>
              <category_list>
                <category>
                  <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>Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity</title>
        <description>Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.</description>
        <time_frame>Baseline to 90 days post-treatment</time_frame>
        <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity</title>
          <description>Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.</description>
          <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
          <units>percentage of participants improved</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quantitative Improvement in Skin Laxity</title>
        <description>Assess change in brachial volume based on brachial tissue measurements.</description>
        <time_frame>Baseline to 90 days post-treatment</time_frame>
        <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Improvement in Skin Laxity</title>
          <description>Assess change in brachial volume based on brachial tissue measurements.</description>
          <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
          <units>percentage of participants improved</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement Left Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improvement Right Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improvement of both Left &amp; Right Arms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dermal Thickness</title>
        <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.</description>
        <time_frame>Baseline to 90 days post-treatment</time_frame>
        <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dermal Thickness</title>
          <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.</description>
          <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
          <units>Millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Difference in Mean Thickness from Baseline - R Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.072" lower_limit="-0.015" upper_limit="0.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in Mean Thickness from Baseline - L Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.082" lower_limit="-0.170" upper_limit="0.296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dermal Thickness</title>
        <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.</description>
        <time_frame>Baseline to180 days post-treatment</time_frame>
        <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dermal Thickness</title>
          <description>Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.</description>
          <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
          <units>Millimeters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Difference in Mean Thickness from Baseline - R Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.099" lower_limit="0.002" upper_limit="0.330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in Mean Thickness from Baseline - L Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.085" lower_limit="0.034" upper_limit="0.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Aesthetic Improvement</title>
        <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
        <time_frame>Baseline to 60 days post-treatment</time_frame>
        <population>Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Aesthetic Improvement</title>
          <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
          <population>Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Aesthetic Improvement</title>
        <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
        <time_frame>Baseline to 90 days post-treatment</time_frame>
        <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Aesthetic Improvement</title>
          <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
          <population>Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Aesthetic Improvement</title>
        <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
        <time_frame>Baseline to180 days post-treatment</time_frame>
        <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Aesthetic Improvement</title>
          <description>Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:&#xD;
- Very Much Improved&#xD;
- Much Improved&#xD;
- Improved&#xD;
- No Change&#xD;
- Worse</description>
          <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subject GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subject GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physician GAIS Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
        <time_frame>Baseline to 90 days post-treatment</time_frame>
        <population>wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
          <population>wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improvement Noticed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
        <time_frame>Baseline to 180 days post-treatment</time_frame>
        <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
        <group_list>
          <group group_id="O1">
            <title>Ultherapy® Treatment</title>
            <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.</description>
          <population>Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Improvement Noticed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ultherapy® Treatment</title>
          <description>Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="37"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>- Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Public Disclosure Manager</name_or_title>
      <organization>Merz Pharmaceuticals</organization>
      <email>clinicaltrials@merz.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/NCT01713933
org study id: ULT-114
nct id: NCT01713933
lead sponsor: 
has dmc: No
This study is an evaluation of the Ulthera® System used to treat the upper arms for
      improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm
      treatment. Follow-up visits will occur at 60, 90 and 180 days post-treatment.
This is a prospective, non-randomized, clinical trial treating up to 35 subjects. Study
      photographs of the upper arms will be taken prior to treatment, immediately post-treatment,
      and at each follow-up visit. Brachial volume and dermal thickness measurements will be
      obtained.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity
time frame: Baseline to 90 days post-treatment
description: Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
measure: Quantitative Improvement in Skin Laxity
time frame: Baseline to 90 days post-treatment
description: Assess change in brachial volume based on brachial tissue measurements.
measure: Change in Dermal Thickness
time frame: Baseline to 90 days post-treatment
description: Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.
measure: Change in Dermal Thickness
time frame: Baseline to180 days post-treatment
description: Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.
measure: Overall Aesthetic Improvement
time frame: Baseline to 60 days post-treatment
description: Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
measure: Overall Aesthetic Improvement
time frame: Baseline to 90 days post-treatment
description: Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
measure: Overall Aesthetic Improvement
time frame: Baseline to180 days post-treatment
description: Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:
- Very Much Improved
- Much Improved
- Improved
- No Change
- Worse
measure: Patient Satisfaction
time frame: Baseline to 90 days post-treatment
description: Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
measure: Patient Satisfaction
time frame: Baseline to 180 days post-treatment
description: Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.
arm group label: Ultherapy™ treatment
arm group type: Experimental
description: Each enrolled subject will receive a bilateral Ultherapy™ treatment of the upper arms
intervention type: Device
intervention name: Ulthera® System
description: Focused ultrasound energy delivered below the surface of the skin.
arm group label: Ultherapy™ treatment
other name: Ultherapy™ treatment
other name: Ulthera, Inc.
other name: Ultrasound treatment for skin tightening
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gordon Sasaki, MD FACS
role: Principal Investigator
affiliation: Sasaki Advanced Aesthetic Medical Center
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: - Poor subject selection (high BMI with large volume arms enrolled rather than subjects with laxity and wrinkled skin)
point of contact: 