<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/NCT01708512</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-130</org_study_id>
    <nct_id>NCT01708512</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Higher Density Ulthera® System Treatment With Vectoring for Treatment of the Face and Neck</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System for Lifting and Tightening of Facial and Neck Skin Laxity Using a Customized, High-Density and Vectoring Treatment Approach</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>
      All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained&#xD;
      pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects&#xD;
      will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera®&#xD;
      System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and&#xD;
      tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at&#xD;
      study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction&#xD;
      questionnaires will also be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in overall lifting and tightening of the skin</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall aesthetic improvement</measure>
    <time_frame>365 days post-treatment</time_frame>
    <description>Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.</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™ study treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive a customized, high-density, vectored 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>Ultherapy™ study treatment</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 25 to 60 years.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Skin laxity in the area(s) to be treated.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             area(s) 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;
        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 area(s) to be treated.&#xD;
&#xD;
          -  Excessive skin laxity on the area(s) to be treated.&#xD;
&#xD;
          -  Significant scarring in area(s) to be treated.&#xD;
&#xD;
          -  Open wounds or lesions in the area(s) to be treated.&#xD;
&#xD;
          -  Severe or cystic acne on the area(s) to be treated.&#xD;
&#xD;
          -  Presence of a metal stent or implant in the area(s) to be treated.&#xD;
&#xD;
          -  Inability to understand the protocol or to give informed consent.&#xD;
&#xD;
          -  BMI equal to and greater than 30.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William P Werschler, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Premier Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</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/NCT01708512
org study id: ULT-130
nct id: NCT01708512
lead sponsor: 
has dmc: No
All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained
      pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects
      will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera®
      System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and
      tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at
      study follow-up visits. 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: Single (Outcomes Assessor)
measure: Improvement in overall lifting and tightening of the skin
time frame: 90 days post-treatment
description: As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure.
measure: Overall aesthetic improvement
time frame: 365 days post-treatment
description: Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos.
arm group label: Ultherapy™ study treatment
arm group type: Experimental
description: Each subject will receive a customized, high-density, vectored 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: Ultherapy™ study treatment
other name: Ultherapy™
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William P Werschler, MD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa