<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/NCT01722461</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-119</org_study_id>
    <nct_id>NCT01722461</nct_id>
  </id_info>
  <brief_title>A Study of the Ulthera® System for the Treatment of Axillary Hyperhidrosis</brief_title>
  <official_title>A Prospective, Multi-Center, Parallel, Randomized, Double-Blinded Study of the Efficacy and Safety of the Ulthera® System for the Treatment of Primary 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will&#xD;
      be randomly assigned to receive either active treatments for axillary hyperhidrosis with the&#xD;
      Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the&#xD;
      energy settings on the device set to deliver no ultrasound energy. Subjects will be&#xD;
      randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one&#xD;
      subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.&#xD;
&#xD;
      Subjects and study personnel conducting efficacy measures will be blinded to the assigned&#xD;
      treatment groups. The study hypothesis is that subjects in the active treatment group will&#xD;
      have a greater reduction in underarm sweating compared to those in the sham group as measured&#xD;
      by a quality of life questionnaire.&#xD;
&#xD;
      All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their&#xD;
      first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their&#xD;
      second study treatment. Subjects in the active treatment group will also undergo follow-up&#xD;
      assessments at 9 months and 12 months from the date of their second study treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision; unexpectedly high sham response at primary outcome time point.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">May 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>Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating</measure>
    <time_frame>30 days post-treatment #2</time_frame>
    <description>As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating</measure>
    <time_frame>6 month post treatment #2</time_frame>
    <description>As measured by the HDSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating</measure>
    <time_frame>12 months post treatment #2</time_frame>
    <description>As measured by the HDSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production</measure>
    <time_frame>3 months post treatment</time_frame>
    <description>As measured by gravimetric method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production</measure>
    <time_frame>Subjects will be followed to 12 months post treatment #2</time_frame>
    <description>As measured by gravimetric method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Primary Axillary Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Active treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ulthera System treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Ulthera System delivering no ultrasound energy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ulthera System</intervention_name>
    <description>Focused ultrasound energy delivered below the surface of the skin</description>
    <arm_group_label>Active treatment</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham treatment</intervention_name>
    <description>Ulthera System delivering no ultrasound energy</description>
    <arm_group_label>Sham treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female, age 18 years or older.&#xD;
&#xD;
          -  Subject is in good health.&#xD;
&#xD;
          -  Diagnosis of primary focal axillary hyperhidrosis evidenced by at least two of the&#xD;
             standard criteria.&#xD;
&#xD;
          -  At least 50mg at 5 min of spontaneous resting axillary sweat production in each axilla&#xD;
             measured gravimetrically&#xD;
&#xD;
          -  A HDSS score of 3 or 4&#xD;
&#xD;
          -  Willingness to comply with study visits and requirements&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative urine pregnancy test&#xD;
             result and must not be lactating at Visit 1&#xD;
&#xD;
          -  Female subjects over 40 years of age must have had a mammogram in the last 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a dermal disorder including infection at anticipated treatment sites in either&#xD;
             axilla.&#xD;
&#xD;
          -  Has had axillary injections of botulinum toxin in the last year.&#xD;
&#xD;
          -  Has an expected use of botulinum toxin for the treatment of any other disease during&#xD;
             the study period.&#xD;
&#xD;
          -  Has a known allergy to starch powder, iodine, or lidocaine.&#xD;
&#xD;
          -  Has secondary hyperhidrosis&#xD;
&#xD;
          -  Has had previous surgical treatment of hyperhidrosis&#xD;
&#xD;
          -  Has had prior miraDry treatment for axillary hyperhidrosis.&#xD;
&#xD;
          -  Has used prescription antiperspirants in the last 14 days or plans to use them during&#xD;
             the study period.&#xD;
&#xD;
          -  Inability to withhold use of non-study-supplied antiperspirants and deodorants&#xD;
&#xD;
          -  Unwillingness to wash off study-supplied antiperspirants and abstain from use for 72&#xD;
             hours prior to treatments or assessments.&#xD;
&#xD;
          -  History of previous Ultherapy™ treatment to the axilla.&#xD;
&#xD;
          -  Has a history of a bleeding disorder&#xD;
&#xD;
          -  Has used of cholinomimetics, anticholinergics, or any oral herbal medicine treatments&#xD;
             for hyperhidrosis in the past 4 weeks.&#xD;
&#xD;
          -  Is a prisoner or under incarceration.&#xD;
&#xD;
          -  Is participating in another clinical trial involving the use of investigational&#xD;
             devices or drugs (or has in the last 30 days.)&#xD;
&#xD;
          -  Has a history of cancer (some exceptions), lymphectomy, or a planned lymphectomy.&#xD;
&#xD;
          -  Has a pacemaker or other electronic implant.&#xD;
&#xD;
          -  Requires supplemental oxygen.&#xD;
&#xD;
          -  Has used antiplatelet agents / Anticoagulants (Coumadin, Pradaxa, Heparin, Plavix) in&#xD;
             the past 6 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark S Nestor, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Center for Clinical and Cosmetic Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roseville Facial Plastic Surgery</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical and Cosmetic Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Few Institute of Aesthetic Plastic Surgery</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Louis University Dermatology</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Day Dermatology &amp; Aesthetics</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 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>Excessive 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/NCT01722461
org study id: ULT-119
nct id: NCT01722461
lead sponsor: 
has dmc: Yes
This is a prospective, multi-center, randomized, double-blinded study. Subjects enrolled will
      be randomly assigned to receive either active treatments for axillary hyperhidrosis with the
      Ulthera System in both axillas, or sham treatments, also with the Ulthera System but with the
      energy settings on the device set to deliver no ultrasound energy. Subjects will be
      randomized in a 2:1 ratio, with 2 subjects randomized to active treatment for every one
      subject randomized to sham treatment. Subjects will receive 2 study treatments 30 days apart.

      Subjects and study personnel conducting efficacy measures will be blinded to the assigned
      treatment groups. The study hypothesis is that subjects in the active treatment group will
      have a greater reduction in underarm sweating compared to those in the sham group as measured
      by a quality of life questionnaire.

      All subjects will undergo follow-up assessments at 14 days and 30 days from the date of their
      first study treatment, and 14 days, 30 days, 3 months and 6 months from the date of their
      second study treatment. Subjects in the active treatment group will also undergo follow-up
      assessments at 9 months and 12 months from the date of their second study treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
time frame: 30 days post-treatment #2
description: As measured by the Hyperhidrosis Disease Severity Scale (HDSS), a quality of life questionnaire
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
time frame: 6 month post treatment #2
description: As measured by the HDSS
measure: Percentage of active treated subjects compared to sham treated subjects with reduced underarm sweating
time frame: 12 months post treatment #2
description: As measured by the HDSS
measure: Percentage of active treated subjects compared to sham treated subjects with reduced average spontaneous axillary sweat production
time frame: 3 months post treatment
description: As measured by gravimetric method
measure: Percentage of active treated subjects compared to sham treated subjects with reduced spontaneous axillary sweat production
time frame: Subjects will be followed to 12 months post treatment #2
description: As measured by gravimetric method
arm group label: Active treatment
arm group type: Experimental
description: Ulthera System treatment
arm group label: Sham treatment
arm group type: Sham Comparator
description: Ulthera System delivering no ultrasound energy
intervention type: Device
intervention name: Ulthera System
description: Focused ultrasound energy delivered below the surface of the skin
arm group label: Active treatment
other name: Ultherapy™
intervention type: Device
intervention name: Sham treatment
description: Ulthera System delivering no ultrasound energy
arm group label: Sham treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark S Nestor, M.D., Ph.D
role: Principal Investigator
affiliation: The Center for Clinical and Cosmetic Research
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis