<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/NCT01713569</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-122</org_study_id>
    <nct_id>NCT01713569</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Histological Characterization After Treatment With the Ulthera® System</brief_title>
  <official_title>Feasibility Study: Histological Characterization of Dermal and Subdermal Thermal Coagulation Points in Rhytidectomy Patients After Treatment With the Ulthera® System</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 6 subjects will be enrolled. Subjects who have already chosen to have a surgical&#xD;
      facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound&#xD;
      exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48&#xD;
      hours post-treatment, on the day of their rhytidectomy. Study images will be obtained&#xD;
      pretreatment, immediately post-treatment, and at the follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single-center clinical trial. Subjects will be enrolled at the&#xD;
      investigator's discretion if they meet inclusion/ exclusion criteria and provide written&#xD;
      informed consent. Enrolled subjects will be treated with an assigned transducer based on&#xD;
      their order of enrollment. At the study follow-up visit, subjects will undergo resection of&#xD;
      the treated tissue for histological analysis prior to their planned rhytidectomy procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow subject enrollment; study to be obtained is no longer required.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the depth of focused thermal injury and thermal injury zone dimensions.</measure>
    <time_frame>48 hours post-treatment</time_frame>
    <description>Post-treatment, treated tissue will be resected for histological analysis.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Subject 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 1.2 Joules and 30 Watts on the Left side versus 0.9 Joules and 30 Watts on the Right side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subject 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 1.05 Joules and 25 Watts on the Left side versus 0.75 Joules and 25 Watts on the Right side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subject 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 0.45 Joules and 15 Watts on the Left side versus 0.35 Joules and 14 Watts on the Right side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subject 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 10 MHz, 1.5mm depth transducer at 0.25 Joules and 5 Watts on the Left side versus 0.18 Joules and 5 Watts on the Right side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subject 5</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus 7 MHz, 4.5mm 0.9 Joules and 25 Watts on the Right side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subject 6</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm transducer at 0.35 and 14 Watts, and a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus a 7 MHz, 3.0mm depth and 4.5mm depth transducer at 2.0 Joules and 40 Watts on the Right side.</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>Subject 1</arm_group_label>
    <arm_group_label>Subject 2</arm_group_label>
    <arm_group_label>Subject 3</arm_group_label>
    <arm_group_label>Subject 4</arm_group_label>
    <arm_group_label>Subject 5</arm_group_label>
    <arm_group_label>Subject 6</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, age 30 to 65 years scheduled for rhytidectomy.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             areas to be treated.&#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;
          -  Severe solar elastosis.&#xD;
&#xD;
          -  Significant scarring in areas to be treated.&#xD;
&#xD;
          -  Open wounds or lesions in the area to be treated.&#xD;
&#xD;
          -  Severe or cystic acne on the area to be treated.&#xD;
&#xD;
          -  Presence of a metal stent or implant in the facial area to be treated.&#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>Gordon Sasaki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sasaki Advanced Aesthetic Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sasaki Advanced Aesthetic Medical Center</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 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/NCT01713569
org study id: ULT-122
nct id: NCT01713569
lead sponsor: 
has dmc: No
Up to 6 subjects will be enrolled. Subjects who have already chosen to have a surgical
      facelift procedure will be enrolled. Subjects will receive selective Ulthera® ultrasound
      exposures in the pre-auricular regions. Subject will return for a follow-up visit up to 48
      hours post-treatment, on the day of their rhytidectomy. Study images will be obtained
      pretreatment, immediately post-treatment, and at the follow-up visit.
This study is a prospective, single-center clinical trial. Subjects will be enrolled at the
      investigator's discretion if they meet inclusion/ exclusion criteria and provide written
      informed consent. Enrolled subjects will be treated with an assigned transducer based on
      their order of enrollment. At the study follow-up visit, subjects will undergo resection of
      the treated tissue for histological analysis prior to their planned rhytidectomy procedure.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: To determine the depth of focused thermal injury and thermal injury zone dimensions.
time frame: 48 hours post-treatment
description: Post-treatment, treated tissue will be resected for histological analysis.
arm group label: Subject 1
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 1.2 Joules and 30 Watts on the Left side versus 0.9 Joules and 30 Watts on the Right side.
arm group label: Subject 2
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 1.05 Joules and 25 Watts on the Left side versus 0.75 Joules and 25 Watts on the Right side.
arm group label: Subject 3
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm depth transducer at 0.45 Joules and 15 Watts on the Left side versus 0.35 Joules and 14 Watts on the Right side.
arm group label: Subject 4
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 10 MHz, 1.5mm depth transducer at 0.25 Joules and 5 Watts on the Left side versus 0.18 Joules and 5 Watts on the Right side.
arm group label: Subject 5
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus 7 MHz, 4.5mm 0.9 Joules and 25 Watts on the Right side.
arm group label: Subject 6
arm group type: Active Comparator
description: Ulthera treatment will be administered to both pre-auricular regions using a 7 MHz, 3.0mm transducer at 0.35 and 14 Watts, and a 4 MHz, 4.5mm depth transducer at 0.9 Joules and 30 Watts on the Left side versus a 7 MHz, 3.0mm depth and 4.5mm depth transducer at 2.0 Joules and 40 Watts on the Right side.
intervention type: Device
intervention name: Ulthera Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Subject 1
arm group label: Subject 2
arm group label: Subject 3
arm group label: Subject 4
arm group label: Subject 5
arm group label: Subject 6
other name: Ultherapy™
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gordon Sasaki, MD
role: Principal Investigator
affiliation: Sasaki Advanced Aesthetic Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa