<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/NCT01713998</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-300</org_study_id>
    <nct_id>NCT01713998</nct_id>
  </id_info>
  <brief_title>Treatment of the Face and Neck With Lower Ulthera System Energy Settings</brief_title>
  <official_title>Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings</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>
      Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on&#xD;
      the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study&#xD;
      images will be obtained pre-treatment, immediately post-treatment, and at each follow-up&#xD;
      visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, single-site, double-blinded, randomized, split-face design.&#xD;
      Subjects will be randomized to one of three treatment groups, receiving treatment using&#xD;
      different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction&#xD;
      questionnaires will be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjects' Assessment of Pain During Treatment With Lower Energy Settings</measure>
    <time_frame>Participants were assessed for the duration of study treatment, an average of 75 minutes</time_frame>
    <description>Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.&#xD;
Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Improvement in Skin Laxity on the Face and Neck</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative Assessment of Brow Lift at 90 Days Post-treatment</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Assessment of Improvement at 90 Days Post-treatment</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Assessment of Improvement at 180 Days Post-treatment</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.</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>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 30 to 65 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Skin laxity on the face and neck&#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 face or neck.&#xD;
&#xD;
          -  Excessive skin laxity on the face or neck.&#xD;
&#xD;
          -  Significant scarring in areas to be treated.&#xD;
&#xD;
          -  Open wounds or lesions in the area to be treated.&#xD;
&#xD;
          -  Severe or cystic acne on the area to be treated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven H Gitt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulthera, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulthera, Inc.</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85210</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>June 19, 2013</results_first_submitted>
  <results_first_submitted_qc>January 6, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 21, 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>
  <keyword>Ultrasound treatment for skin tightening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cutis Laxa</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Forty-seven subjects were enrolled, randomized, and treated. The first subject treated on 10/4/2011; the last subject treated on 2/13/12; the last follow-up was 10/11/12.&#xD;
Enrolled subjects were randomized to one of three study groups (Group A, B, or C).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.</description>
        </group>
        <group group_id="P3">
          <title>Group C</title>
          <description>Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </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 group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
        </group>
        <group group_id="B3">
          <title>Group C</title>
          <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="47"/>
          </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="54" lower_limit="37" upper_limit="64"/>
                    <measurement group_id="B2" value="55" lower_limit="42" upper_limit="64"/>
                    <measurement group_id="B3" value="51" lower_limit="36" upper_limit="64"/>
                    <measurement group_id="B4" value="53" lower_limit="36" upper_limit="64"/>
                  </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="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </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="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (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" lower_limit="20" upper_limit="29"/>
                    <measurement group_id="B2" value="24" lower_limit="19" upper_limit="28"/>
                    <measurement group_id="B3" value="24" lower_limit="20" upper_limit="29"/>
                    <measurement group_id="B4" value="24" lower_limit="19" upper_limit="29"/>
                  </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&#xD;
Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty&#xD;
Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans&#xD;
Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease&#xD;
Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily&#xD;
Skin Type VI = Black; Never burns, tans very easily</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Skin Type I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Type II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Type III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Type IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Type V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin Type VI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjects' Assessment of Pain During Treatment With Lower Energy Settings</title>
        <description>Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.&#xD;
Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.</description>
        <time_frame>Participants were assessed for the duration of study treatment, an average of 75 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.</description>
          </group>
        </group_list>
        <measure>
          <title>Subjects' Assessment of Pain During Treatment With Lower Energy Settings</title>
          <description>Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.&#xD;
Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standard Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="O2" value="6.0" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="O3" value="5.6" lower_limit="3" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="1" upper_limit="9"/>
                    <measurement group_id="O2" value="3.7" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O3" value="5.9" lower_limit="3" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Improvement in Skin Laxity on the Face and Neck</title>
        <description>A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.</description>
        <time_frame>90 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Improvement in Skin Laxity on the Face and Neck</title>
          <description>A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quantitative Assessment of Brow Lift at 90 Days Post-treatment</title>
        <description>Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.</description>
        <time_frame>90 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.</description>
          </group>
        </group_list>
        <measure>
          <title>Quantitative Assessment of Brow Lift at 90 Days Post-treatment</title>
          <description>Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standard Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Assessment of Improvement at 90 Days Post-treatment</title>
        <description>Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
        <time_frame>90 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Assessment of Improvement at 90 Days Post-treatment</title>
          <description>Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standard Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Assessment of Improvement at 180 Days Post-treatment</title>
        <description>Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
        <time_frame>180 days post-treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Assessment of Improvement at 180 Days Post-treatment</title>
          <description>Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Standard Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="73"/>
                    <measurement group_id="O3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adjusted Energy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Study Population</title>
          <description>Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.</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="47"/>
              </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="47"/>
              </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/NCT01713998
org study id: ULT-300
nct id: NCT01713998
lead sponsor: 
has dmc: No
Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on
      the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study
      images will be obtained pre-treatment, immediately post-treatment, and at each follow-up
      visit.
This trial is a prospective, single-site, double-blinded, randomized, split-face design.
      Subjects will be randomized to one of three treatment groups, receiving treatment using
      different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction
      questionnaires will be obtained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Subjects' Assessment of Pain During Treatment With Lower Energy Settings
time frame: Participants were assessed for the duration of study treatment, an average of 75 minutes
description: Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.
Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed.
measure: Overall Improvement in Skin Laxity on the Face and Neck
time frame: 90 days post-treatment
description: A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.
measure: Quantitative Assessment of Brow Lift at 90 Days Post-treatment
time frame: 90 days post-treatment
description: Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.
measure: Subject Assessment of Improvement at 90 Days Post-treatment
time frame: 90 days post-treatment
description: Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
measure: Subject Assessment of Improvement at 180 Days Post-treatment
time frame: 180 days post-treatment
description: Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
arm group label: Group A
arm group type: Active Comparator
description: Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.
arm group label: Group B
arm group type: Active Comparator
description: Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.
arm group label: Group C
arm group type: Active Comparator
description: Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Group A
arm group label: Group B
arm group label: Group C
other name: Ultherapy™
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven H Gitt, MD
role: Principal Investigator
affiliation: Ulthera, Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 