<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/NCT01708928</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-107</org_study_id>
    <nct_id>NCT01708928</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Lifting and Tightening Neck Skin in Patients</brief_title>
  <official_title>Feasibility Study: Evaluation Of The Ulthera™ System For Obtaining Lift And Tightening Of The Neck Skin In Patients With A History Of Submentoplasty And Or Rhytidectomy Vs Patients Naïve To Submentoplasty Or Rhytidectomy - A Feasibility Study</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 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the&#xD;
      lower two thirds of the face and neck. Subjects will be equally grouped into those with a&#xD;
      history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or&#xD;
      rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.&#xD;
      Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each&#xD;
      follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective single center study. Subjects will be enrolled one per group as they&#xD;
      present. Efficacy will be determined by the change in submental volume and cervicomental&#xD;
      angle. GAIS and patient satisfaction questionnaires will also be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in submental volume</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall improvement of the submental area</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</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 who have previous history of submentoplasty and or rhytidectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects naïve to submentoplasty and or rhytidectomy</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>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 30 to 65 years&#xD;
&#xD;
          -  Subject in good health&#xD;
&#xD;
          -  Body Mass index of less than 30&#xD;
&#xD;
          -  Present with unwanted skin laxity in the submental area as demonstrated by a grade 2&#xD;
             or 3 on the Knize scale for classification of cosmetic deformity of the cervicomental&#xD;
             angle&#xD;
&#xD;
          -  Previous history of surgical submentoplasty and or rhytidectomy greater than 12 months&#xD;
             previous to enrollment and not to exceed 120 months prior to enrollment&#xD;
&#xD;
          -  Understands and accepts the obligation not to receive any other procedures in the&#xD;
             submental areas thru the 6 month follow up visit&#xD;
&#xD;
          -  Willingness and ability to comply with protocol requirements including returning for&#xD;
             follow-up visits and abstaining from exclusionary procedures for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Subjects of childbearing potential must have a negative urine pregnancy test result at&#xD;
             Visit 1 and be willing able to use an acceptable method of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, lactating or planning to become pregnant and or not using a reliable form of&#xD;
             birth control&#xD;
&#xD;
          -  Has an active systemic or local skin disease that may alter wound healing&#xD;
&#xD;
          -  Subjects with a prior cosmetic or medical history of submentoplasty and or&#xD;
             Rhytidectomy within the last 12 months or greater than 120 months&#xD;
&#xD;
          -  Subjects with a prior cosmetic or medical history of submentoplasty and or&#xD;
             Rhytidectomy&#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 Dayan, MD</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>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 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/NCT01708928
org study id: ULT-107
nct id: NCT01708928
lead sponsor: 
has dmc: No
Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the
      lower two thirds of the face and neck. Subjects will be equally grouped into those with a
      history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or
      rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.
      Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each
      follow-up visit.
This is a prospective single center study. Subjects will be enrolled one per group as they
      present. Efficacy will be determined by the change in submental volume and cervicomental
      angle. GAIS and patient satisfaction questionnaires will also be obtained.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in submental volume
time frame: 90 days post-treatment
description: Measured by the Canfield Vectra® imaging system comparing pre-treatment baseline photos to post-treatment photos.
measure: Overall improvement of the submental area
time frame: 90 days post-treatment
description: Global Aesthetic Improvement Scale (GAIS) and patient satisfaction questionnaires will be obtained.
arm group label: Group A
arm group type: Active Comparator
description: Subjects who have previous history of submentoplasty and or rhytidectomy
arm group label: Group B
arm group type: Active Comparator
description: Subjects naïve to submentoplasty and or rhytidectomy
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
other name: Ultherapy™
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Dayan, MD
role: Principal Investigator
affiliation: DeNova Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa