<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/NCT01713959</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-121</org_study_id>
    <nct_id>NCT01713959</nct_id>
  </id_info>
  <brief_title>Feasibility Study: Ulthera® System for the Treatment of Axillary Hyperhidrosis</brief_title>
  <official_title>Feasibility Study: Evaluation of the Safety and Efficacy of the Ulthera® System for the Treatment of Axillary Hyperhidrosis</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>
      Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two&#xD;
      treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at&#xD;
      7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days&#xD;
      post-treatment #2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized to one of two study groups:&#xD;
&#xD;
        -  Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other&#xD;
           axilla.&#xD;
&#xD;
        -  Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine&#xD;
           injection administered to one axillary side.&#xD;
&#xD;
      Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be&#xD;
      obtained at all study visits. Patient satisfaction questionnaires will also be obtained at&#xD;
      30, 60 and 90 days post-treatment #2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">April 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in sweat production</measure>
    <time_frame>90-days post-treatment treatment #2</time_frame>
    <description>Axillary hyperhidrosis as assessed by using a gravimetric method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in sweat production at follow-up timepoints other than 90 days post-treatment</measure>
    <time_frame>Participants will be followed up to 60 days post-treatment</time_frame>
    <description>Axillary hyperhidrosis as assessed by using a gravimetric method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area of efficacy</measure>
    <time_frame>Participants will be followed for up to 90 days following treatment #2.</time_frame>
    <description>Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative measure of hyperhidrosis severity</measure>
    <time_frame>Participants will be followed for up to 90 days following treatment #2</time_frame>
    <description>The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Group A - Split Body Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Ulthera System Treatment w lido</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera System treatment</intervention_name>
    <description>Ulthera System: Focused ultrasound energy delivered below the surface of the skin.</description>
    <arm_group_label>Group A - Split Body Treatment</arm_group_label>
    <arm_group_label>Group B: Ulthera System Treatment w lido</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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham treatment</intervention_name>
    <description>Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.</description>
    <arm_group_label>Group A - Split Body Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female, ages 18-75&#xD;
&#xD;
          -  Subject is in good health&#xD;
&#xD;
          -  Diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies&#xD;
&#xD;
          -  At least 50 mg of spontaneous resting axillary sweat production in each axilla&#xD;
             measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a&#xD;
             period of 5 minutes. (Patients should be at rest for at least 30 minutes after&#xD;
             physical exercise including walking.)&#xD;
&#xD;
          -  HDSS score of 3 or 4.&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dermal disorder including infection at anticipated treatment sites in either axilla.&#xD;
&#xD;
          -  Previous botulinum toxin treatment of the axilla in the past year.&#xD;
&#xD;
          -  Expected use of botulinum toxin for the treatment of any other disease during the&#xD;
             study period.&#xD;
&#xD;
          -  Known allergy to starch powder or iodine.&#xD;
&#xD;
          -  Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other&#xD;
             underlying diseases including hyperthyroidism, lymphoma and malaria.&#xD;
&#xD;
          -  Previous surgical treatment of hyperhidrosis including sympathectomy, surgical&#xD;
             debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.&#xD;
&#xD;
          -  Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during&#xD;
             the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Nestor, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Center for Clinical &amp; Cosmetic Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Center for Clinical &amp; Cosmetic Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</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 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>Underarm sweating</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhidrosis</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/NCT01713959
org study id: ULT-121
nct id: NCT01713959
lead sponsor: 
has dmc: No
Single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two
      treatment groups. Subjects will receive two Ultherapy treatments at Day 0 with follow-ups at
      7 and 14 days post-treatment #1, and Day 28 with follow-ups are 7, 14, 30, 60, 90 days
      post-treatment #2.
Subjects will be randomized to one of two study groups:

        -  Group A: Split body treatment. Ultherapy to one axilla, Sham treatment to the other
           axilla.

        -  Group B: Bilateral Ultherapy treatments, with a pre-treatment subcutaneous lidocaine
           injection administered to one axillary side.

      Hyperhidrosis Disease Severity Scale (HDSS), gravimetric test and starch iodine test will be
      obtained at all study visits. Patient satisfaction questionnaires will also be obtained at
      30, 60 and 90 days post-treatment #2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in sweat production
time frame: 90-days post-treatment treatment #2
description: Axillary hyperhidrosis as assessed by using a gravimetric method.
measure: Improvement in sweat production at follow-up timepoints other than 90 days post-treatment
time frame: Participants will be followed up to 60 days post-treatment
description: Axillary hyperhidrosis as assessed by using a gravimetric method.
measure: Area of efficacy
time frame: Participants will be followed for up to 90 days following treatment #2.
description: Starch iodine test will be used to assess the area of efficacy. Imaging will be obtained.
measure: Qualitative measure of hyperhidrosis severity
time frame: Participants will be followed for up to 90 days following treatment #2
description: The HDSS is a scale used for primary axillary/underarm hyperhidrosis patients. It provides a qualitative measure of the severity of their condition based on how it affects their daily activities. Patients select the statement that best reflects their experience with underarm sweating.
arm group label: Group A - Split Body Treatment
arm group type: Experimental
description: Active treatment of one axilla with the Ulthera System Treatment; Sham treatment of one axilla.
arm group label: Group B: Ulthera System Treatment w lido
arm group type: Active Comparator
description: Subjects receive a bilateral Ulthera System Treatment, with one axilla receiving a subcutaneous lidocaine injection.
intervention type: Device
intervention name: Ulthera System treatment
description: Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
arm group label: Group A - Split Body Treatment
arm group label: Group B: Ulthera System Treatment w lido
other name: Ulthera® System
other name: Ultherapy™ Treatment
other name: Ulthera, Inc.
other name: Ultrasound treatment for skin tightening
intervention type: Device
intervention name: Sham treatment
description: Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
arm group label: Group A - Split Body Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark Nestor, MD, Ph.D
role: Principal Investigator
affiliation: The Center for Clinical & Cosmetic Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis