<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/NCT01708382</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-108</org_study_id>
    <nct_id>NCT01708382</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Lifting and Tightening of the Elbows</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of the Elbow Tissue - 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 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on&#xD;
      the elbows. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will&#xD;
      be obtained pre-treatment, immediately 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 skin laxity above the elbows. Masked assessment of pre- and&#xD;
      post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and&#xD;
      patient satisfaction questionnaires will also be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">September 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>Overall improvement of skin laxity in the areas treated</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aesthetic improvement</measure>
    <time_frame>90 and 180 days post-treatment</time_frame>
    <description>GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Ultherapy treatment on the elbows</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled subjects will receive one Ultherapy treatment to the elbows.</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>Ultherapy treatment on the elbows</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 21 to 65 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Mild to moderate skin laxity on the elbows.&#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, 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&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  Excessive subcutaneous fat around the elbows.&#xD;
&#xD;
          -  Excessive skin laxity around the elbows.&#xD;
&#xD;
          -  Significant scarring in areas to be treated.&#xD;
&#xD;
          -  Significant open wounds or lesions in the area to be treated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cameron K Rokhsar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Cosmetic, Skin, and Laser Surgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Cosmetic, Skin and Laser Surgery Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</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 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/NCT01708382
org study id: ULT-108
nct id: NCT01708382
lead sponsor: 
has dmc: No
Up to 20 subjects will be treated. Treated subjects will receive one Ulthera® treatment on
      the elbows. 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 skin laxity above the elbows. Masked assessment of pre- and
      post-treatment photos will be performed. Global Aesthetic Improvement Scale scores and
      patient satisfaction questionnaires will also be obtained.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall improvement of skin laxity in the areas treated
time frame: 90 days post-treatment
description: Determined by masked assessment analysis of photographs at 90 days post treatment compared to baseline.
measure: Aesthetic improvement
time frame: 90 and 180 days post-treatment
description: GAIS scores will be obtained by the Investigator and subjects at all visits excluding baseline. Additionally, subject satisfaction questionnaires will also be obtained.
arm group label: Ultherapy treatment on the elbows
arm group type: Experimental
description: All enrolled subjects will receive one Ultherapy treatment to the elbows.
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Ultherapy treatment on the elbows
other name: Ultherapy™
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cameron K Rokhsar, MD
role: Principal Investigator
affiliation: New York Cosmetic, Skin, and Laser Surgery Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa