<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/NCT01708460</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-118</org_study_id>
    <nct_id>NCT01708460</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Ulthera Treatment of the Buttocks and Thighs</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening the Buttocks and Thighs</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. Enrolled subjects will receive an Ulthera® treatment to&#xD;
      one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90&#xD;
      and 180 days post-treatment. Study images will be obtained pre-treatment, immediately&#xD;
      post-treatment, and at each follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the&#xD;
      Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale&#xD;
      scores and patient satisfaction questionnaires will be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">January 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall lifting and tightening of the buttocks and thighs.</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall aesthetic improvement.</measure>
    <time_frame>90 and 180 days post-treatment.</time_frame>
    <description>As determined by GAIS completed by the Investigator and subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall subject satisfaction.</measure>
    <time_frame>90 and 180 days post-treatment</time_frame>
    <description>As determined by subjects' completion of a Patient Satisfaction Questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Ulthera-treated subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.</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-treated subjects</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 in the buttocks and thighs.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             areas to be treated and/or weight loss through the follow-up period.&#xD;
&#xD;
          -  Willingness and ability to comply with protocol requirements, including returning for&#xD;
             follow-up visits and abstaining from exclusionary procedures for the duration of the&#xD;
             study.&#xD;
&#xD;
          -  Subjects of childbearing potential must have a negative urine pregnancy test result&#xD;
             and must not be lactating at Visit 1 and be willing and able to use an acceptable&#xD;
             method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal&#xD;
             methods, IUD, surgical sterilization, abstinence) during the study. Women will not be&#xD;
             considered of childbearing potential if one of the following conditions is documented&#xD;
             on the medical history: a) Postmenopausal for at least 12 months prior to study; b)&#xD;
             Without a uterus and/or both ovaries; or c) A bilateral tubal ligation at least six&#xD;
             months prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  BMI equal to or greater than 40.&#xD;
&#xD;
          -  Excessive subcutaneous fat in the buttocks and thighs.&#xD;
&#xD;
          -  Excessive skin laxity in the buttocks and thighs.&#xD;
&#xD;
          -  Significant weight fluctuation (±10 lbs) in the past 6 months.&#xD;
&#xD;
          -  Taking weight-loss medications/supplements.&#xD;
&#xD;
          -  Surgical or non-surgical treatments to the target areas in the last 12 months, e.g.,&#xD;
             liposuction.&#xD;
&#xD;
          -  Inability to understand the protocol or to give informed consent.&#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>David Goldberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin Laser and Surgery Specialist of New York and New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skin Laser and Surgery Specialist of New York and New Jersey</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>November 21, 2017</last_update_submitted>
  <last_update_submitted_qc>November 21, 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/NCT01708460
org study id: ULT-118
nct id: NCT01708460
lead sponsor: 
has dmc: No
Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to
      one side of the body, treating the lateral buttock region. 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 is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the
      Ulthera® System to improve buttock and thigh skin laxity. 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: Overall lifting and tightening of the buttocks and thighs.
time frame: 90 days post-treatment
description: As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline.
measure: Overall aesthetic improvement.
time frame: 90 and 180 days post-treatment.
description: As determined by GAIS completed by the Investigator and subject.
measure: Overall subject satisfaction.
time frame: 90 and 180 days post-treatment
description: As determined by subjects' completion of a Patient Satisfaction Questionnaire.
arm group label: Ulthera-treated subjects
arm group type: Experimental
description: All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body.
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin.
arm group label: Ulthera-treated subjects
other name: Ultherapy™
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Goldberg, MD
role: Principal Investigator
affiliation: Skin Laser and Surgery Specialist of New York and New Jersey
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa