<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/NCT01708551</url>
  </required_header>
  <id_info>
    <org_study_id>ULT-134</org_study_id>
    <nct_id>NCT01708551</nct_id>
  </id_info>
  <brief_title>Histological Analysis Following Ulthera System Treatment for Hyperhidrosis</brief_title>
  <official_title>Histological Analysis and Correlation With Ultrasound Imaging to Evaluate the Safety and Effectiveness of Treating Axillary Hyperhidrosis Subjects With the Ulthera® System</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 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in&#xD;
      Groups A, B or C will undergo axillary punch biopsies during the course of the trial to&#xD;
      determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm&#xD;
      and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A&#xD;
      and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will&#xD;
      receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment&#xD;
      depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol&#xD;
      amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy&#xD;
      setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40&#xD;
      lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days&#xD;
      post-treatment #2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects&#xD;
      enrolled will include:&#xD;
&#xD;
        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth&#xD;
           treatment at 4.5mm and 3.0mm;&#xD;
&#xD;
        -  those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group&#xD;
           B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;&#xD;
&#xD;
        -  those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one&#xD;
           double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;&#xD;
&#xD;
        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth&#xD;
           treatment at 2.0mm at standard energy;&#xD;
&#xD;
        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth&#xD;
           treatment at 2.0mm at adjusted energy.&#xD;
&#xD;
        -  Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the&#xD;
           same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment&#xD;
           square; Group E, 40 lines per treatment square.&#xD;
&#xD;
      Ultrasound images will be captured of each axilla to assess dermal thickness and depth of&#xD;
      sweat glands. A gravimetric measurement of sweat production and starch iodine test will be&#xD;
      performed prior to treatment. Digital images of the starch iodine test will be obtained.&#xD;
      Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment.&#xD;
      During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla&#xD;
      treated. Efficacy will be determined by a reduction in the number of sweat glands from&#xD;
      baseline to 90-days post-treatment, as evidenced by histological analysis. Subject&#xD;
      Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to&#xD;
      baseline will also be analyzed as secondary outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the number of sweat glands from baseline to 90-days post-treatment.</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment</measure>
    <time_frame>7 days post-treatment</time_frame>
    <description>A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment</measure>
    <time_frame>30 days post-treatment</time_frame>
    <description>A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment</measure>
    <time_frame>180 days post-treatment</time_frame>
    <description>A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDSS score reduction</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>HDSS score reduction from a 3 or 4 to a 1 or 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Starch iodine test</measure>
    <time_frame>90 days post-treatment</time_frame>
    <description>Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.</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>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <other_name>Ultherapy™</other_name>
  </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;
          -  Groups A, C, D and E: At least 50 mg of spontaneous resting axillary sweat production&#xD;
             in each axilla measured gravimetrically at room temperature / humidity (20 -&#xD;
             25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30&#xD;
             minutes after physical exercise including walking.) Group B: A mean of &gt;50mg/5min of&#xD;
             sweat production following a prior Ultherapy treatment.&#xD;
&#xD;
          -  A HDSS score is 3 or 4. An attempt will be made to approximate an equal number of&#xD;
             scores 3 and 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;
          -  Absence of physical conditions unacceptable to the investigator.&#xD;
&#xD;
          -  Willingness and ability to provide written informed consent and HIPAA authorization&#xD;
             prior to performance of any study-related procedure.&#xD;
&#xD;
          -  Subjects of childbearing potential must have a negative urine pregnancy test result&#xD;
             and must not be lactating at Visit 1 and be willing and able to use an acceptable&#xD;
             method of birth control.&#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, iodine, lidocaine, or epinephrine.&#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;
          -  Unwillingness to wash off deodorants and abstain use 72 hours prior to treatments or&#xD;
             assessments.&#xD;
&#xD;
          -  Subjects with a history of a bleeding disorder&#xD;
&#xD;
          -  Use of cholinomimetics, anticholinergics, or any oral herbal medicine treatments for&#xD;
             hyperhidrosis.&#xD;
&#xD;
          -  Inability to withhold use of antiperspirants and deodorants, or any other topical&#xD;
             treatments for hyperhidrosis within 72 hours prior to study treatments and&#xD;
             assessments.&#xD;
&#xD;
          -  Unwillingness for complete shaving or removal of underarm hair within 12 hours prior&#xD;
             to study treatments and follow-up visits.&#xD;
&#xD;
          -  Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during&#xD;
             the study period.&#xD;
&#xD;
          -  Inability to understand the protocol or to give informed consent.&#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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Center for Clinical and Cosmetic Research</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</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>
  <disposition_first_submitted>December 13, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>December 13, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 14, 2017</disposition_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperhidrosis</keyword>
  <keyword>Axillary sweating</keyword>
  <keyword>Ulthera® System</keyword>
  <keyword>Ultherapy™ Treatment</keyword>
  <keyword>Ulthera, Inc.</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, but a results disposition has been submitted           -->
</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/NCT01708551
org study id: ULT-134
nct id: NCT01708551
lead sponsor: 
has dmc: No
Up to 60 subjects will be enrolled into one of five treatment groups. Subjects enrolled in
      Groups A, B or C will undergo axillary punch biopsies during the course of the trial to
      determine the number and depth of the sweat glands, and receive dual depth treatments (4.5mm
      and 3.0mm); either two bilateral Ultherapy™ treatments to the axillas 30 days apart (Groups A
      and B) or one bilateral Ultherapy™ treatment (Group C). Subjects in Groups D and E will
      receive two bilateral Ultherapy™ treatments to the axillas 30 days apart at a 2.0mm treatment
      depth and two different energy settings (Group D at 0.45 J, Group E at 0.30 J). Protocol
      amended (Sept 2014): Subjects in Groups D and E will receive treatments at the same energy
      setting (0.30J) and two treatment densities: Group D, 60 lines/treatment square; Group E, 40
      lines per treatment square. Follow-up visits will occur at 7, 30, 90 and 180 days
      post-treatment #2.
This study is a prospective, single-center, non-randomized pilot clinical trial. Subjects
      enrolled will include:

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group A, n=31); dual-depth
           treatment at 4.5mm and 3.0mm;

        -  those who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis (Group
           B, n=approx 5), dual-depth treatment at 4.5mm and 3.0mm;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis who will receive one
           double-density study treatment (Group C, n=4), dual-depth treatment at 4.5mm and 3.0mm;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group D, n=10), single-depth
           treatment at 2.0mm at standard energy;

        -  those naïve to Ultherapy™ for treatment of hyperhidrosis (Group E, n=10), single-depth
           treatment at 2.0mm at adjusted energy.

        -  Protocol amended (Sept 2014): Subjects in Groups D and E will receive treatments at the
           same energy setting (0.30J) and two treatment densities: Group D, 60 lines/treatment
           square; Group E, 40 lines per treatment square.

      Ultrasound images will be captured of each axilla to assess dermal thickness and depth of
      sweat glands. A gravimetric measurement of sweat production and starch iodine test will be
      performed prior to treatment. Digital images of the starch iodine test will be obtained.
      Hyperhidrosis Disease Severity Scale (HDSS)scores will be obtained prior to each treatment.
      During treatment, the average Numeric Rating Scale (NRS) score will be obtained by axilla
      treated. Efficacy will be determined by a reduction in the number of sweat glands from
      baseline to 90-days post-treatment, as evidenced by histological analysis. Subject
      Gravimetric results, Starch iodine results, and HDSS scores at all follow-ups compared to
      baseline will also be analyzed as secondary outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction in the number of sweat glands from baseline to 90-days post-treatment.
time frame: 90 days post-treatment
description: Based on histological analyses of biopsied, Ultherapy™-treated, tissue, the changed in the number of sweat glands present at 90days post-treatment will be compared to the number of sweat glands present at baseline.
measure: Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
time frame: 7 days post-treatment
description: A 50% reduction or more in Gravimetric measure at 7 days post-treatment compared to baseline.
measure: Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
time frame: 30 days post-treatment
description: A 50% reduction or more in Gravimetric measure at 30 days post-treatment compared to baseline.
measure: Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
time frame: 90 days post-treatment
description: A 50% reduction or more in Gravimetric measure at 90 days post-treatment compared to baseline.
measure: Reduction in spontaneous axillary sweat production assessed by gravimetric method at 90-days post treatment
time frame: 180 days post-treatment
description: A 50% reduction or more in Gravimetric measure at 180 days post-treatment compared to baseline.
measure: HDSS score reduction
time frame: 90 days post-treatment
description: HDSS score reduction from a 3 or 4 to a 1 or 2
measure: Starch iodine test
time frame: 90 days post-treatment
description: Assess the reduction in starch iodine test area at 90 days post-treatment compared to baseline.
arm group label: Group A
arm group type: Active Comparator
description: Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
arm group label: Group B
arm group type: Active Comparator
description: Subjects who were non-responders to a prior Ultherapy™ treatment for hyperhidrosis will receive bilateral Ulthera System treatments; dual depth treatment at 4.5mm and 3.0mm.
arm group label: Group C
arm group type: Active Comparator
description: Subjects will receive one double-density Ulthera System treatment; dual depth treatment at 4.5mm and 3.0mm.
arm group label: Group D
arm group type: Active Comparator
description: Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and standard energy level.
arm group label: Group E
arm group type: Active Comparator
description: Subjects naïve to Ultherapy™ for treatment of hyperhidrosis will receive bilateral Ulthera System treatments at 2.0mm treatment depth and adjusted energy level.
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
arm group label: Group C
arm group label: Group D
arm group label: Group E
other name: Ultherapy™
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mark Nestor, MD, PhD
role: Principal Investigator
affiliation: The Center for Clinical and Cosmetic Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis