<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/NCT02193139</url>
  </required_header>
  <id_info>
    <org_study_id>OH1304</org_study_id>
    <nct_id>NCT02193139</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of an Anticholinergic Agent for Treatment of Primary Axillary Hyperhidrosis</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Watson Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Watson Pharmaceuticals</source>
  <brief_summary>
    <textblock>
      This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing&#xD;
      medication and identify the dose or doses that may effectively reduce axillary sweating in&#xD;
      hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gravimetric measurement of sweat production</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hyperhidrosis Disease Severity Scale (HDSS) scores</measure>
    <time_frame>6 weeks</time_frame>
    <description>Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI) scores</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change from baseline in DLQI total score at Week 6 (LOCF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Disease State responses</measure>
    <time_frame>6 weeks</time_frame>
    <description>Global Assessment of Disease State score at Week 6 (LOCF)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">195</enrollment>
  <condition>Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>WL8713, 6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 mg WL8713 administered daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL8713, 12 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 mg WL8713 administered daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL8713, 18 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18 mg WL8713 administered daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WL8713, 24 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 mg WL8713 administered daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo administered daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WL8713, 6 mg</intervention_name>
    <arm_group_label>WL8713, 6 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WL8713, 12 mg</intervention_name>
    <arm_group_label>WL8713, 12 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WL8713, 18 mg</intervention_name>
    <arm_group_label>WL8713, 18 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WL8713, 24 mg</intervention_name>
    <arm_group_label>WL8713, 24 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers with primary axillary hyperhidrosis&#xD;
&#xD;
          -  Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or&#xD;
             4)&#xD;
&#xD;
          -  Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100&#xD;
             mg/10 min at room at room temperature in at least one axilla&#xD;
&#xD;
          -  Meets at least two of the following criteria (self-reported):&#xD;
&#xD;
               -  sweating is bilateral and symmetrical&#xD;
&#xD;
               -  excessive sweating impairs daily activities&#xD;
&#xD;
               -  subject experiences at least one sweating episode per week&#xD;
&#xD;
               -  excessive sweating onset was earlier than age 25 years&#xD;
&#xD;
               -  has a positive family history for excessive sweating&#xD;
&#xD;
               -  cessation of sweating during sleep&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Watson Clinical Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <disposition_first_submitted>July 15, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>July 15, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">August 6, 2015</disposition_first_posted>
  <last_update_submitted>July 15, 2015</last_update_submitted>
  <last_update_submitted_qc>July 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</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>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/NCT02193139
org study id: OH1304
nct id: NCT02193139
lead sponsor: 
This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing
      medication and identify the dose or doses that may effectively reduce axillary sweating in
      hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gravimetric measurement of sweat production
time frame: 6 weeks
description: Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
measure: Hyperhidrosis Disease Severity Scale (HDSS) scores
time frame: 6 weeks
description: Percentage of subjects with a change from baseline in HDSS scores of at least -2 points at Week 6 (LOCF)
measure: Dermatology Life Quality Index (DLQI) scores
time frame: 6 weeks
description: Change from baseline in DLQI total score at Week 6 (LOCF)
measure: Global Assessment of Disease State responses
time frame: 6 weeks
description: Global Assessment of Disease State score at Week 6 (LOCF)
arm group label: WL8713, 6 mg
arm group type: Experimental
description: 6 mg WL8713 administered daily
arm group label: WL8713, 12 mg
arm group type: Experimental
description: 12 mg WL8713 administered daily
arm group label: WL8713, 18 mg
arm group type: Experimental
description: 18 mg WL8713 administered daily
arm group label: WL8713, 24 mg
arm group type: Experimental
description: 24 mg WL8713 administered daily
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo administered daily
intervention type: Drug
intervention name: WL8713, 6 mg
arm group label: WL8713, 6 mg
intervention type: Drug
intervention name: WL8713, 12 mg
arm group label: WL8713, 12 mg
intervention type: Drug
intervention name: WL8713, 18 mg
arm group label: WL8713, 18 mg
intervention type: Drug
intervention name: WL8713, 24 mg
arm group label: WL8713, 24 mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis