<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/NCT01713985</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-135</org_study_id>
    <nct_id>NCT01713985</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck</brief_title>
  <official_title>Feasibility Study: Evaluation of the Ulthera® System vs Thermage® for Lifting and Tightening of the Full Face and Neck</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 enrolled and randomly assigned to one of two treatment groups.&#xD;
      Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the&#xD;
      left side. Group B will receive Thermage on the right side of the face and neck and&#xD;
      Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment.&#xD;
      Study images will be obtained pre-treatment, immediately post-treatment, and at each&#xD;
      follow-up visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A&#xD;
      triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects&#xD;
      to the full half face, neck, and submental areas. Changes in face and neck skin laxity and&#xD;
      wrinkles, from baseline and between study treatments, will be assessed at study follow-up&#xD;
      visits. Patient satisfaction questionnaires will also be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Lifting and Tightening of Skin</measure>
    <time_frame>180 days post treatment</time_frame>
    <description>Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Wrinkle Reduction</measure>
    <time_frame>180 days post treatment</time_frame>
    <description>Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Eyebrow Lift</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Lower face and Neck Lift</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Treatment Satisfaction</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Skin Laxity</condition>
  <condition>Wrinkles</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera System Treatment Right, Thermage Left</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ulthera System Treatment Left, Thermage Right</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>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermage</intervention_name>
    <description>Radiofrequency treatment focusing radiofrequency energy</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </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 on the area(s) to be treated.&#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 in the area(s) to be treated.&#xD;
&#xD;
          -  Excessive skin laxity on the area(s) to be treated.&#xD;
&#xD;
          -  Significant scarring in the 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;
          -  Microdermabrasion, or prescription level glycolic acid treatment to the treatment&#xD;
             area(s) within two weeks prior to study participation or during the study.&#xD;
&#xD;
          -  Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick&#xD;
             sebaceous skin in the area(s) to be treated.&#xD;
&#xD;
          -  BMI equal to or greater than 25.&#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>Steven Cohen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faces+</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FACES+</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</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 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 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/NCT01713985
org study id: ULT-135
nct id: NCT01713985
lead sponsor: 
has dmc: No
Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups.
      Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the
      left side. Group B will receive Thermage on the right side of the face and neck and
      Ultherapy™ on the left side. 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, double-blinded, split-face, randomized pilot study. A
      triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects
      to the full half face, neck, and submental areas. Changes in face and neck skin laxity and
      wrinkles, from baseline and between study treatments, will be assessed at study follow-up
      visits. Patient satisfaction questionnaires will also be obtained.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of Participants with Lifting and Tightening of Skin
time frame: 180 days post treatment
description: Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in skin laxity will be assessed based on photographs taken using the 3D Vectra digital imaging system.
measure: Number of Participants with Wrinkle Reduction
time frame: 180 days post treatment
description: Determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline. Improvement in wrinkle reduction will be assessed based on photographs taken using the 3D Vectra digital imaging system
measure: Number of Participants with Eyebrow Lift
time frame: 90 days post-treatment
description: Quantitative measurements of eyebrow lift will be obtained at follow-up compared to baseline.
measure: Number of Participants with Lower face and Neck Lift
time frame: 90 days post-treatment
description: Quantitative measurements of lower face and neck lift will be obtained at follow-up compared to baseline.
measure: Number of Participants Reporting Treatment Satisfaction
time frame: 180 days post-treatment
description: Subjects will complete a split-face Patient Satisfaction Questionnaire at 180 days following study treatments.
arm group label: Group A
arm group type: Active Comparator
description: Ulthera System Treatment Right, Thermage Left
arm group label: Group B
arm group type: Active Comparator
description: Ulthera System Treatment Left, Thermage Right
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Group A
arm group label: Group B
other name: Ultherapy™
intervention type: Device
intervention name: Thermage
description: Radiofrequency treatment focusing radiofrequency energy
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Cohen, MD
role: Principal Investigator
affiliation: Faces+
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa