<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/NCT01708447</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-117</org_study_id>
    <nct_id>NCT01708447</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment</brief_title>
  <official_title>Feasibility Study: Evaluation of the Efficacy of a Liposome-encapsulated Lidocaine Topical Anesthetic for Reducing Discomfort Associated With Ultherapy™ Treatment</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>
      This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for&#xD;
      reducing discomfort associated with Ultherapy™ treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes&#xD;
      prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the&#xD;
      face and neck and a placebo cream with similar consistency and color will be applied to the&#xD;
      other side of the face and neck, in a randomized fashion. The subject and investigator or&#xD;
      sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the&#xD;
      topical anesthetic is applied. Pain scores will be collected following treatment of each&#xD;
      section of the face and neck on both sides. Subjects will return for a 90-day post-treatment&#xD;
      visit to assess improvement in skin laxity, and overall lifting and tightening of skin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-related pain</measure>
    <time_frame>During treatment</time_frame>
    <description>The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in skin laxity.</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Topical anesthetic - L.M.X.4.® cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L.M.X.4.® cream</intervention_name>
    <description>A lidocaine topical anesthetic cream</description>
    <arm_group_label>Topical anesthetic - L.M.X.4.® cream</arm_group_label>
    <other_name>A lidocaine topical anesthetic cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A placebo cream</intervention_name>
    <description>Placebo cream containing no anesthetic properties.</description>
    <arm_group_label>Placebo cream</arm_group_label>
  </intervention>
  <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>Placebo cream</arm_group_label>
    <arm_group_label>Topical anesthetic - L.M.X.4.® cream</arm_group_label>
    <other_name>Ulthera® System</other_name>
    <other_name>Ultherapy™ Treatment</other_name>
    <other_name>Ulthera, Inc.</other_name>
    <other_name>Ultrasound treatment for skin tightening</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 30 to 65 years.&#xD;
&#xD;
          -  Chosen an Ultherapy™ treatment as part of their treatment regimen.&#xD;
&#xD;
          -  Subject in good health.&#xD;
&#xD;
          -  Skin laxity on the face and neck.&#xD;
&#xD;
          -  Understands and accepts the obligation not to undergo any other procedures in the&#xD;
             areas to be treated through the followup 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;
          -  Known sensitivity to lidocaine or any other anesthetic of the amide type.&#xD;
&#xD;
          -  History of anaphylactic shock.&#xD;
&#xD;
          -  Presence of an active systemic or local skin disease that may affect wound healing.&#xD;
&#xD;
          -  Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine).&#xD;
&#xD;
          -  Known or suspected hypersensitivity to LMX-4 active substance, or any of the&#xD;
             amide-type local anaesthetics, or any of the excipients (protocol section 10.3).&#xD;
&#xD;
          -  Severe solar elastosis.&#xD;
&#xD;
          -  Excessive subcutaneous fat in the face and neck.&#xD;
&#xD;
          -  Body mass index of 30 or greater.&#xD;
&#xD;
          -  Excessive skin laxity on the face and neck.&#xD;
&#xD;
          -  Significant scarring in areas to be treated.&#xD;
&#xD;
          -  Significant open facial wounds or lesions.&#xD;
&#xD;
          -  Severe or cystic acne on the face.&#xD;
&#xD;
          -  Presence of a metal stent or implant in the facial area 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>Steven Gitt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Valley Plastic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Valley Plastic Surgery</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85050</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cutis Laxa</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01708447
org study id: ULT-117
nct id: NCT01708447
lead sponsor: 
has dmc: No
This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for
      reducing discomfort associated with Ultherapy™ treatment.
All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes
      prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the
      face and neck and a placebo cream with similar consistency and color will be applied to the
      other side of the face and neck, in a randomized fashion. The subject and investigator or
      sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the
      topical anesthetic is applied. Pain scores will be collected following treatment of each
      section of the face and neck on both sides. Subjects will return for a 90-day post-treatment
      visit to assess improvement in skin laxity, and overall lifting and tightening of skin.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Treatment-related pain
time frame: During treatment
description: The validated 10-point pain NRS scale will be used to measure average pain scores reported by subject immediately after each facial region is treated.
measure: Improvement in skin laxity.
time frame: 90 days post-treatment
description: Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
arm group label: Topical anesthetic - L.M.X.4.® cream
arm group type: Active Comparator
description: Topical anesthetic cream, L.M.X.4.® cream, applied to one side of the face and neck prior to Ulthera System treatment.
arm group label: Placebo cream
arm group type: Placebo Comparator
description: A placebo cream with similar consistency and color will be applied to the other side of the face and neck prior to Ulthera System treatment.
intervention type: Drug
intervention name: L.M.X.4.® cream
description: A lidocaine topical anesthetic cream
arm group label: Topical anesthetic - L.M.X.4.® cream
other name: A lidocaine topical anesthetic cream
intervention type: Other
intervention name: A placebo cream
description: Placebo cream containing no anesthetic properties.
arm group label: Placebo cream
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Placebo cream
arm group label: Topical anesthetic - L.M.X.4.® cream
other name: Ulthera® System
other name: Ultherapy™ Treatment
other name: Ulthera, Inc.
other name: Ultrasound treatment for skin tightening
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Gitt, MD
role: Principal Investigator
affiliation: North Valley Plastic Surgery
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa
mesh term: Lidocaine
mesh term: Anesthetics, Local
mesh term: Anesthetics