<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/NCT03037788</url>
  </required_header>
  <id_info>
    <org_study_id>Hyp-02/2015</org_study_id>
    <secondary_id>2015-005570-38</secondary_id>
    <nct_id>NCT03037788</nct_id>
  </id_info>
  <brief_title>Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis</brief_title>
  <official_title>Pharmacokinetics, Local and Systemic Tolerability and Local Efficacy of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in a Placebo Controlled, Double Blind Study in Subjects With Axillary Hyperhidrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. August Wolff GmbH &amp; Co. KG Arzneimittel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nuvisan GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FGK Clinical Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles River Biopharmaceutical Services GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr. August Wolff GmbH &amp; Co. KG Arzneimittel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and&#xD;
      efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 1</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>Tolerability and safety assessed through adverse events and local skin reactions</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gravimetric measurement of sweat production</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperhidrosis Disease Severity Scale (HDSS)</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Primary Axillary Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>WO3979</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Formulation containing WO3979 for topical application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WO3970</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Formulation containing WO3970 for topical application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WO3992</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Formulation containing WO3992 for topical application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo of WO3988</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Formulation containing Placebo of WO3988 for topical application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WO3979</intervention_name>
    <description>Application of cream to each axilla</description>
    <arm_group_label>WO3979</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WO3970</intervention_name>
    <description>Application of cream to each axilla</description>
    <arm_group_label>WO3970</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WO3992</intervention_name>
    <description>Application of cream to each axilla</description>
    <arm_group_label>WO3992</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (WO3988)</intervention_name>
    <description>Application of cream to each axilla</description>
    <arm_group_label>Placebo of WO3988</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of moderate to severe primary axillary hyperhidrosis whose HDSS score is 2,&#xD;
             3 or 4&#xD;
&#xD;
          -  At least 50 mg in males or 25 mg in females of spontaneous resting axillary sweat&#xD;
             production in one axilla measured gravimetrically at room temperature/humidity (about&#xD;
             25°C / 20-50%) over a period of 5 minutes.&#xD;
&#xD;
          -  Male and female subjects in the age of 18 to 65 years at the time of informed consent&#xD;
             and a body mass index (BMI) of 18-32 kg/m2.&#xD;
&#xD;
          -  Corrected QT (QTc) ≤450 msec, or QTc &lt;480 msec in subjects with bundle branch block.&#xD;
&#xD;
          -  Able to comply with protocol requirements, including overnight stays, blood sample&#xD;
             collections as defined in the protocol subjects.&#xD;
&#xD;
          -  Willing and able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any of the components in the investigational product.&#xD;
&#xD;
          -  Hypersensitivity against glycopyrrolate&#xD;
&#xD;
          -  Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other&#xD;
             underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric&#xD;
             hyperhidrosis.&#xD;
&#xD;
          -  Previous surgical treatment of hyperhidrosis including sympathectomy, surgical&#xD;
             debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.&#xD;
&#xD;
          -  Botulinum toxin treatment in the prior 9 months.&#xD;
&#xD;
          -  Present or history of neuromuscular disease.&#xD;
&#xD;
          -  Angle closure glaucoma or its precipitation (narrow angle).&#xD;
&#xD;
          -  Mycotic, other skin infections and other dermal disorder including infection at&#xD;
             anticipated application sites in either axilla.&#xD;
&#xD;
          -  Significant cardiac arrhythmia such as tachycardiac atrial fibrillation and very&#xD;
             frequent extrasystoles.&#xD;
&#xD;
          -  Subject with diabetes mellitus.&#xD;
&#xD;
          -  Subjects with ileus, gastrointestinal stenosis, pronounced chronic inflammatory bowel&#xD;
             disease, toxic megacolon.&#xD;
&#xD;
          -  Subjects with epilepsy.&#xD;
&#xD;
          -  Use of antiperspirants containing aluminium chloride and deodorants, any oral herbal&#xD;
             medicine treatments or any other topical treatments for hyperhidrosis within 7 days&#xD;
             prior to study treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Christoph Abels, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dr. August Wolff GmbH &amp; Co. KG Arzneimittel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Horst Jürgen Heuer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nuvisan GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nuvisan GmbH</name>
      <address>
        <city>Neu-Ulm</city>
        <zip>89231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Excessive sweating</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhidrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037788
org study id: Hyp-02/2015
secondary id: 2015-005570-38
nct id: NCT03037788
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of the study is to assess the safety, tolerability, pharmacokinetics (PK) and
      efficacy of escalating concentrations of GPB in subjects with axillary hyperhidrosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Tolerability and safety assessed through adverse events and local skin reactions
time frame: 3 weeks
measure: Gravimetric measurement of sweat production
time frame: 3 weeks
measure: Dermatology Life Quality Index (DLQI)
time frame: 3 weeks
measure: Hyperhidrosis Disease Severity Scale (HDSS)
time frame: 3 weeks
arm group label: WO3979
arm group type: Experimental
description: Formulation containing WO3979 for topical application
arm group label: WO3970
arm group type: Experimental
description: Formulation containing WO3970 for topical application
arm group label: WO3992
arm group type: Experimental
description: Formulation containing WO3992 for topical application
arm group label: Placebo of WO3988
arm group type: Placebo Comparator
description: Formulation containing Placebo of WO3988 for topical application
intervention type: Drug
intervention name: WO3979
description: Application of cream to each axilla
arm group label: WO3979
intervention type: Drug
intervention name: WO3970
description: Application of cream to each axilla
arm group label: WO3970
intervention type: Drug
intervention name: WO3992
description: Application of cream to each axilla
arm group label: WO3992
intervention type: Drug
intervention name: Placebo (WO3988)
description: Application of cream to each axilla
arm group label: Placebo of WO3988
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Prof. Christoph Abels, MD, PhD
role: Study Director
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
last name: Horst Jürgen Heuer, MD
role: Principal Investigator
affiliation: Nuvisan GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hyperhidrosis
sharing ipd: No