<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/NCT01708252</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-127</org_study_id>
    <nct_id>NCT01708252</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Neck in Post-Surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ultherapy™ Treatment</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 10 subjects will be enrolled. All subjects will receive an increased density&#xD;
      UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face&#xD;
      and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be&#xD;
      obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-site, non-randomized clinical trial efficacy of an additional&#xD;
      Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous&#xD;
      Ulthera clinical trial. 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">August 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in lower face and neck skin laxity</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Efficacy will be assessed using the 90-day images compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervicomental angle</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Efficacy will be assessed using the 90-day images compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall aesthetic improvement</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment</measure>
    <time_frame>Treatment visit</time_frame>
    <description>Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall aesthetic improvement</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Ulthera treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will receive an Ulthera System Treatment</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 treatment group</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;
          -  BMI &lt; 30.&#xD;
&#xD;
          -  Skin laxity in the submental area as demonstrated by a grade II or III on the Knize&#xD;
             scale for classification of cosmetic deformity of the cervicomental angle&#xD;
&#xD;
          -  Previous participation in ULT-107, and adequate compliance with all treatment and&#xD;
             follow-up visits. Groups (surgery or surgery naïve) will be designated based on group&#xD;
             assigned in ULT-107).&#xD;
&#xD;
          -  Have not had any concomitant surgical or skin tightening procedures since their&#xD;
             Ultherapy™ treatment with ULT-107.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, lactating, or are planning to become pregnant, and/or not using a reliable&#xD;
             form of birth control.&#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 on the cheeks.&#xD;
&#xD;
          -  Excessive skin laxity on the lower face and 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 Dayan, MD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>DeNova Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DeNova Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 7, 2011</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01708252
org study id: ULT-127
nct id: NCT01708252
lead sponsor: 
has dmc: No
Up to 10 subjects will be enrolled. All subjects will receive an increased density
      UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face
      and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be
      obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional
      Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous
      Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction
      questionnaires will be obtained.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in lower face and neck skin laxity
time frame: 90 days post-treatment
description: Efficacy will be assessed using the 90-day images compared to baseline
measure: Cervicomental angle
time frame: 90 days post-treatment
description: Efficacy will be assessed using the 90-day images compared to baseline.
measure: Overall aesthetic improvement
time frame: 90 days post-treatment
description: Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment.
measure: Patient satisfaction
time frame: 90 days post-treatment
description: Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment.
measure: Pain Assessment
time frame: Treatment visit
description: Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment.
measure: Patient Satisfaction
time frame: 180 days post-treatment
description: Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment.
measure: Overall aesthetic improvement
time frame: 180 days post-treatment
description: Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment.
arm group label: Ulthera treatment group
arm group type: Experimental
description: All subjects will receive an Ulthera System Treatment
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Ulthera treatment group
other name: Ultherapy™
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven H Dayan, MD, FACS
role: Principal Investigator
affiliation: DeNova Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa