<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/NCT01713686</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-129</org_study_id>
    <nct_id>NCT01713686</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ulthera System for the Treatment of the Decolletage</brief_title>
  <official_title>Prospective, Multi-center, Pivotal Trial Evaluating the Safety and Effectiveness of the Ulthera® System for Improvement in Lines and Wrinkles of the Décolletage</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera®&#xD;
      treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following&#xD;
      treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at&#xD;
      each follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment</measure>
    <time_frame>90 Days post-treatment</time_frame>
    <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment</measure>
    <time_frame>180 days post treatment</time_frame>
    <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Aesthetic Improvement at 90 Days Post-treatment</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Aesthetic Improvement at 180 Days Post-treatment</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction at 90 Days Post-treatment</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot;= Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot;=Dissatisfied + Very Dissatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction at 180 Days Post-treatment</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot; = Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot; = Dissatisfied + Very Dissatisfied</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Chest Wrinkles</condition>
  <arm_group>
    <arm_group_label>Ulthera System Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera System Treatment</intervention_name>
    <description>Focused ultrasound energy delivered below the surface of the skin</description>
    <arm_group_label>Ulthera System Treatment</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, aged 35 to 70 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest&#xD;
             wrinkle scale.&#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.&#xD;
&#xD;
          -  Subjects of childbearing potential must have a negative urine pregnancy test result&#xD;
             and must not be lactating.&#xD;
&#xD;
          -  Absence of physical conditions unacceptable to the investigator.&#xD;
&#xD;
          -  Willingness and ability to provide written consent for study-required photography.&#xD;
&#xD;
          -  Willingness and ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  Scarring in areas to be treated.&#xD;
&#xD;
          -  Tattoos in the areas to be treated.&#xD;
&#xD;
          -  Patients with ports or defibrillators.&#xD;
&#xD;
          -  Any open wounds or lesions in the area.&#xD;
&#xD;
          -  Active and severe inflammatory acne in the region to be treated.&#xD;
&#xD;
          -  Patients who have a history with keloid formation or hypertrophic scarring.&#xD;
&#xD;
          -  Inability to understand the protocol or to give informed consent.&#xD;
&#xD;
          -  Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the&#xD;
             décolletage area within two weeks prior to study participation or during the study.&#xD;
&#xD;
          -  Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring,&#xD;
             or thick sebaceous skin.&#xD;
&#xD;
          -  History of chronic drug or alcohol abuse.&#xD;
&#xD;
          -  History of autoimmune disease.&#xD;
&#xD;
          -  Concurrent therapy that would interfere with the evaluation of the safety or&#xD;
             effectiveness of the study device.&#xD;
&#xD;
          -  Subjects who anticipate the need for surgery or overnight hospitalization during the&#xD;
             study.&#xD;
&#xD;
          -  Subjects who have a history of poor cooperation, noncompliance with medical treatment,&#xD;
             or unreliability.&#xD;
&#xD;
          -  Concurrent enrollment in any study involving the use of investigational devices or&#xD;
             drugs.&#xD;
&#xD;
          -  Current smoker or history of smoking in the last one year.&#xD;
&#xD;
          -  History of using the following prescription medications:&#xD;
&#xD;
               1. Topical Retinoids to the area within the past two weeks;&#xD;
&#xD;
               2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).&#xD;
&#xD;
               3. Psychiatric drugs that would impair the subject from understanding the protocol&#xD;
                  requirements or understanding and signing the informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchel P Goldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser Skin and Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denova Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</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 22, 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 20, 2015</results_first_submitted>
  <results_first_submitted_qc>March 2, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 9, 2015</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>
  <keyword>Micro-focused Ultrasound with Visualization (MFU-V)</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ulthera System Treatment</title>
          <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125">129 enrolled, 125 treated. 2 withdrew consent prior to treatment; 2 excluded after enrollment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </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="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ulthera System Treatment</title>
          <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="125"/>
          </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="56.7" lower_limit="37.5" upper_limit="70.4"/>
                  </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="125"/>
                  </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>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick's Sun-Reactive Skin Type</title>
          <description>A classification for skin color:&#xD;
Type I Pale white; blond or red hair; blue eyes; freckles - Always burns, never tans;&#xD;
Type II White; fair; blond or red hair; blue, green or hazel eyes - Usually burns, tans minimally;&#xD;
Type III Cream white; fair with any hair or eye color; quite common - Sometimes mild burn, tans uniformly;&#xD;
Type IV Moderate brown; typical Mediterranean skin tone - Rarely burns, always tans well;&#xD;
Type V Dark brown; Middle Eastern skin types - Very rarely burns, tans very easily;&#xD;
Type VI Deeply pigmented dark brown to 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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.7" lower_limit="18.3" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fabi/Bolton Score</title>
          <description>5-point photonumeric scale, with the following descriptors:&#xD;
Wrinkles absent&#xD;
Shallow lines, but visible&#xD;
Moderately deep lines&#xD;
Deep with well-defined lines&#xD;
Very deep with redundant folds</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Fabi/Bolton Score 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fabi/Bolton Score 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fabi/Bolton Score 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fabi/Bolton Score 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fabi/Bolton Score 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment</title>
        <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
        <time_frame>90 Days post-treatment</time_frame>
        <population>The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as 'missing' by the statistician and were not included in the denominator for the masked assessment analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment</title>
          <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
          <population>The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as 'missing' by the statistician and were not included in the denominator for the masked assessment analyses.</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="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improvement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incorrect</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Aesthetic Improvement at 90 Days Post-treatment</title>
        <description>The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
        <time_frame>90 days post-treatment</time_frame>
        <population>This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Aesthetic Improvement at 90 Days Post-treatment</title>
          <description>The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
          <population>This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.</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="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Aesthetic Improvement at 180 Days Post-treatment</title>
        <description>The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
        <time_frame>180 days post-treatment</time_frame>
        <population>Analysis population was based the number of subjects completing a 180 day follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Aesthetic Improvement at 180 Days Post-treatment</title>
          <description>The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:&#xD;
Very much improved&#xD;
Much improved&#xD;
Improved&#xD;
No change&#xD;
Worse&#xD;
The scale was completed in two steps:&#xD;
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and&#xD;
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.&#xD;
&quot;Improved&quot; = Very Much Improved + Much Improved + Improved</description>
          <population>Analysis population was based the number of subjects completing a 180 day follow-up visit.</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="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment</title>
        <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
        <time_frame>180 days post treatment</time_frame>
        <population>The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment</title>
          <description>Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.&#xD;
&quot;Improvement&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set and correctly chose the Post treatment photo.&#xD;
&quot;Incorrect&quot; = a blinded evaluator assessed an &quot;Improvement&quot; when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.</description>
          <population>The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.</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="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Incorrect</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction at 90 Days Post-treatment</title>
        <description>Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot;= Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot;=Dissatisfied + Very Dissatisfied</description>
        <time_frame>90 days post-treatment</time_frame>
        <population>This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction at 90 Days Post-treatment</title>
          <description>Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot;= Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot;=Dissatisfied + Very Dissatisfied</description>
          <population>This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.</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="116"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither Satisfied or Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction at 180 Days Post-treatment</title>
        <description>Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot; = Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot; = Dissatisfied + Very Dissatisfied</description>
        <time_frame>180 days post-treatment</time_frame>
        <population>This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Ulthera System Treatment</title>
            <description>A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction at 180 Days Post-treatment</title>
          <description>Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:&#xD;
Very Satisfied&#xD;
Satisfied&#xD;
Neither Satisfied or Dissatisfied&#xD;
Dissatisfied&#xD;
Very Dissatisfied&#xD;
&quot;Satisfied&quot; = Very Satisfied + Satisfied&#xD;
&quot;Dissatisfied&quot; = Dissatisfied + Very Dissatisfied</description>
          <population>This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.</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="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfied (satisfied and very satisfied)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neither Satisfied nor Dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dissatisfied (dissatisfied and very dissatisfied)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were followed for up to 6 months post-treatment or until event resolution.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ulthera System Treatment</title>
          <description>A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.&#xD;
Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin</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="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="83" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" events="45" subjects_affected="45" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pruitus</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="125"/>
              </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>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/NCT01713686
org study id: ULT-129
nct id: NCT01713686
lead sponsor: 
has dmc: Yes
This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera®
      treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following
      treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at
      each follow-up visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment
time frame: 90 Days post-treatment
description: Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.
"Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
"Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
measure: Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment
time frame: 180 days post treatment
description: Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.
"Improvement" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set and correctly chose the Post treatment photo.
"Incorrect" = a blinded evaluator assessed an "Improvement" when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo.
measure: Overall Aesthetic Improvement at 90 Days Post-treatment
time frame: 90 days post-treatment
description: The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
Very much improved
Much improved
Improved
No change
Worse
The scale was completed in two steps:
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.
"Improved" = Very Much Improved + Much Improved + Improved
measure: Overall Aesthetic Improvement at 180 Days Post-treatment
time frame: 180 days post-treatment
description: The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:
Very much improved
Much improved
Improved
No change
Worse
The scale was completed in two steps:
Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and
Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.
"Improved" = Very Much Improved + Much Improved + Improved
measure: Subject Satisfaction at 90 Days Post-treatment
time frame: 90 days post-treatment
description: Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
Very Satisfied
Satisfied
Neither Satisfied or Dissatisfied
Dissatisfied
Very Dissatisfied
"Satisfied"= Very Satisfied + Satisfied
"Dissatisfied"=Dissatisfied + Very Dissatisfied
measure: Subject Satisfaction at 180 Days Post-treatment
time frame: 180 days post-treatment
description: Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:
Very Satisfied
Satisfied
Neither Satisfied or Dissatisfied
Dissatisfied
Very Dissatisfied
"Satisfied" = Very Satisfied + Satisfied
"Dissatisfied" = Dissatisfied + Very Dissatisfied
arm group label: Ulthera System Treatment
arm group type: Experimental
description: A single triple-depth Ulthera System treatment of the decolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Ulthera System Treatment
other name: Ultherapy™
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchel P Goldman, MD
role: Principal Investigator
affiliation: Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 