<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/NCT01713907</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-109</org_study_id>
    <nct_id>NCT01713907</nct_id>
  </id_info>
  <brief_title>Evaluation of the Ulthera® System for Treatment of the Face and Neck</brief_title>
  <official_title>Evaluation of the Ulthera® System for Obtaining Lift and Tightening of the Facial Tissue and Improvement in Jawline Definition and Submental Skin Laxity</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 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on&#xD;
      the face and neck. Follow-up visits will occur at 45, 90 and 180 days post-treatment. Study&#xD;
      images will be obtained pre-treatment, immediately post-treatment, and at each follow-up&#xD;
      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 jawline definition and submental skin laxity. Changes from&#xD;
      baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at&#xD;
      study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction&#xD;
      questionnaires, and quality of life questionnaires will be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inadequate study staff to appropriately manage trial.&#xD;
  </why_stopped>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</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 facial wrinkles and lifting and tightening of skin</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall aesthetic improvement</measure>
    <time_frame>Participants will be followed up to 180 days post-treatment</time_frame>
    <description>Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patient satisfaction</measure>
    <time_frame>90 and 180 day post-treatment</time_frame>
    <description>Determined based on Patient Satisfaction and Quality of Life questionnaire scores.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Wrinkles</condition>
  <condition>Rhytids</condition>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Ulthera® treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All enrolled subjects will receive one full face and neck Ulthera® treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera® Treatment</intervention_name>
    <description>Focused ultrasound energy delivered below the surface of the skin.</description>
    <arm_group_label>Ulthera® treatment</arm_group_label>
    <other_name>Ultherapy™ System</other_name>
    <other_name>Ulthera, Inc.</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;
          -  Score of 1 to 6 on the Fitzpatrick's Classification of Wrinkling Scale.&#xD;
&#xD;
          -  Mild to moderate rhytids in the periorbital or perioral region.&#xD;
&#xD;
          -  Mild to moderate laxity in the areas to be treated, which includes length and depth of&#xD;
             lines.&#xD;
&#xD;
          -  Mild to moderate vertical perioral lines&#xD;
&#xD;
          -  Mild to moderate marionette lines.&#xD;
&#xD;
          -  Subjects who desire lift and tightening of periorbital, perioral, and cheek tissue,&#xD;
             improvement in jawline definition and/or submental skin laxity&#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;
        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 on the cheek.&#xD;
&#xD;
          -  Excessive skin laxity on the lower face and neck.&#xD;
&#xD;
          -  Deep wrinkles, numerous lines, with or without redundant skin in the areas to be&#xD;
             treated.&#xD;
&#xD;
          -  Excessive hooding with or without redundant skin in the areas 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>Hema Sundaram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology, Cosmetic &amp; Laser Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology, Cosmetic &amp; Laser Surgery</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 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>Ultherapy™ treatment</keyword>
  <keyword>Ulthera® System</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/NCT01713907
org study id: ULT-109
nct id: NCT01713907
lead sponsor: 
has dmc: No
Up to 15 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on
      the face and neck. Follow-up visits will occur at 45, 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 jawline definition and submental skin laxity. Changes from
      baseline in the Fitzpatrick Facial Wrinkle Scale and facial pigmentation will be assessed at
      study follow-up visits. Global Aesthetic Improvement Scale scores, patient satisfaction
      questionnaires, and quality of life questionnaires will be obtained.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in facial wrinkles and lifting and tightening of skin
time frame: 90 days post-treatment
description: Outcome measure determined based on a masked, qualitative assessment of standardized photographs at 90 days post-treatment compared to baseline
measure: Overall aesthetic improvement
time frame: Participants will be followed up to 180 days post-treatment
description: Aesthetic improvement determined based on GAIS scores at follow-up, and the change in facial pigmentation and Fitzpatrick Facial Wrinkle Scale scores from baseline.
measure: Overall patient satisfaction
time frame: 90 and 180 day post-treatment
description: Determined based on Patient Satisfaction and Quality of Life questionnaire scores.
arm group label: Ulthera® treatment
arm group type: Experimental
description: All enrolled subjects will receive one full face and neck Ulthera® treatment.
intervention type: Device
intervention name: Ulthera® Treatment
description: Focused ultrasound energy delivered below the surface of the skin.
arm group label: Ulthera® treatment
other name: Ultherapy™ System
other name: Ulthera, Inc.
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hema Sundaram, MD
role: Principal Investigator
affiliation: Dermatology, Cosmetic & Laser Surgery
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa