<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/NCT01708473</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-123</org_study_id>
    <nct_id>NCT01708473</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Compare the Effectiveness Between Two Pain Medications When Used Prior to Ultherapy™ Treatments</brief_title>
  <official_title>Feasibility Study: Comparison Of Advil® Vs. Lortab® 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 compare the effectiveness of two pain medications for reducing discomfort&#xD;
      during an Ultherapy treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, single-site, double-blinded, randomized trial. All study&#xD;
      subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized&#xD;
      to receive one of two pain medications prior to treatment. Each subject will be asked to rate&#xD;
      the level of discomfort during the Ultherapy treatment. All study subjects will be followed&#xD;
      for 90 days following treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Treatment discomfort</measure>
    <time_frame>During treatment</time_frame>
    <description>The validated NRS scale will be used to measure average pain scores reported by subject during treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in skin laxity</measure>
    <time_frame>90 days following 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">20</enrollment>
  <condition>Skin Laxity</condition>
  <arm_group>
    <arm_group_label>Advil with Ultherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lortab with Ultherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Advil</intervention_name>
    <description>One (1) tablet 800 mg Advil one hour prior to treatment.</description>
    <arm_group_label>Advil with Ultherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lortab</intervention_name>
    <description>One (1) tablet 10/500 mg of Lortab one hour prior to treatment.</description>
    <arm_group_label>Lortab with Ultherapy</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>Advil with Ultherapy</arm_group_label>
    <arm_group_label>Lortab with Ultherapy</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;
          -  Subject in good health&#xD;
&#xD;
          -  Skin laxity on the upper and lower 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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to ibuprofen, acetaminophen, or opiates&#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 face and neck&#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>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>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>
  <!-- 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/NCT01708473
org study id: ULT-123
nct id: NCT01708473
lead sponsor: 
has dmc: No
This study will compare the effectiveness of two pain medications for reducing discomfort
      during an Ultherapy treatment.
This trial is a prospective, single-site, double-blinded, randomized trial. All study
      subjects will receive a full face and neck Ultherapy treatment. Subjects will be randomized
      to receive one of two pain medications prior to treatment. Each subject will be asked to rate
      the level of discomfort during the Ultherapy treatment. All study subjects will be followed
      for 90 days following treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Treatment discomfort
time frame: During treatment
description: The validated NRS scale will be used to measure average pain scores reported by subject during treatment.
measure: Improvement in skin laxity
time frame: 90 days following treatment
description: Improvement in overall lifting and tightening of skin as determined by a masked, qualitative assessment of photographs.
arm group label: Advil with Ultherapy
arm group type: Active Comparator
description: Subjects randomized to this study arm will receive Advil prior to an Ulthera System Treatment.
arm group label: Lortab with Ultherapy
arm group type: Active Comparator
description: Subjects randomized to this study arm will receive Lortab prior to an Ulthera System Treatment.
intervention type: Drug
intervention name: Advil
description: One (1) tablet 800 mg Advil one hour prior to treatment.
arm group label: Advil with Ultherapy
intervention type: Drug
intervention name: Lortab
description: One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
arm group label: Lortab with Ultherapy
intervention type: Device
intervention name: Ulthera System Treatment
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Advil with Ultherapy
arm group label: Lortab with Ultherapy
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: Hema Sundaram, MD
role: Principal Investigator
affiliation: Dermatology, Cosmetic & Laser Surgery
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cutis Laxa