<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/NCT03024255</url>
  </required_header>
  <id_info>
    <org_study_id>BBI-4000-CL-203</org_study_id>
    <nct_id>NCT03024255</nct_id>
  </id_info>
  <brief_title>A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Botanix Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Botanix Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to assess the safety and efficacy of 3 concentrations of&#xD;
      BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the&#xD;
      Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with&#xD;
      Axillary Hyperhidrosis.&#xD;
&#xD;
      Safety will be assessed through collection of vital signs, adverse events, local skin&#xD;
      responses, hematology, serum chemistry laboratory testing and urinalysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">September 19, 2017</completion_date>
  <primary_completion_date type="Actual">September 19, 2017</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>Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy</measure>
    <time_frame>overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.</time_frame>
    <description>11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).&#xD;
The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity</measure>
    <time_frame>Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)</time_frame>
    <description>Subjects reporting more than one adverse event are counted only once using the highest severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population</measure>
    <time_frame>Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57</time_frame>
    <description>Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed.&#xD;
Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">227</enrollment>
  <condition>Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>BBI-4000 gel, 5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BBI-4000 gel, 5% applied once to each axilla daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBI-4000 gel, 10%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BBI-4000 gel, 10% applied once to each axilla daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BBI-4000 gel, 15%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BBI-4000 gel, 15% applied once to each axilla daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, applied once to each axilla daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBI-4000 gel, 5%</intervention_name>
    <description>BBI-4000 gel, 5% applied once to each axilla daily</description>
    <arm_group_label>BBI-4000 gel, 5%</arm_group_label>
    <other_name>BBI-4000 Low Concentration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBI-4000 gel, 10%</intervention_name>
    <description>BBI-4000 gel, 10% applied once to each axilla daily</description>
    <arm_group_label>BBI-4000 gel, 10%</arm_group_label>
    <other_name>BBI-4000 Medium Concentration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBI-4000 gel, 15%</intervention_name>
    <description>BBI-4000 gel, 15% applied once to each axilla daily</description>
    <arm_group_label>BBI-4000 gel, 15%</arm_group_label>
    <other_name>BBI-4000 High Concentration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle (Placebo)</intervention_name>
    <description>Placebo, applied once to each axilla daily</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject ≥ 18 years of age.&#xD;
&#xD;
          -  Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a)&#xD;
             symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c)&#xD;
             HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of&#xD;
             at least 150 mg.&#xD;
&#xD;
          -  The ability to understand and follow all study-related procedures including study drug&#xD;
             administration.&#xD;
&#xD;
          -  Sexually active female of childbearing potential (FOCBP)* must agree to periodic&#xD;
             pregnancy testing and use a medically acceptable method of contraception while&#xD;
             receiving protocol-assigned product.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the Investigators opinion, any skin or subcutaneous tissue conditions of the&#xD;
             axilla(s).&#xD;
&#xD;
          -  Prior use of any prohibited medication(s) or procedure(s) within the specified&#xD;
             timeframe for the treatment of axillary hyperhidrosis.&#xD;
&#xD;
          -  Anticholinergic agents used to treat conditions such as, but not limited to,&#xD;
             hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by&#xD;
             any route of administration.&#xD;
&#xD;
          -  Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.&#xD;
&#xD;
          -  Use of any cholinergic drug (e.g. bethanechol) within 30 days.&#xD;
&#xD;
          -  Known cause of hyperhidrosis or known history of a condition that may cause&#xD;
             hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism,&#xD;
             diabetes mellitus, medications, etc.).&#xD;
&#xD;
          -  Subjects with unstable diabetes mellitus or thyroid disease, history of renal or&#xD;
             hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease,&#xD;
             obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions,&#xD;
             Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate&#xD;
             sweat production by the use of anticholinergics in the investigator's opinion.&#xD;
&#xD;
          -  Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of&#xD;
             the components of the topical formulation.&#xD;
&#xD;
          -  Subject is pregnant, lactating or is planning to become pregnant during the study.&#xD;
&#xD;
          -  History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial&#xD;
             fibrillation or atrial flutter.&#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>Patricia Walker, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Botanix Pharmaceuticals</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>December 20, 2022</results_first_submitted>
  <results_first_submitted_qc>April 20, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2023</results_first_posted>
  <disposition_first_submitted>July 17, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>July 18, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 20, 2018</disposition_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sweat gland disease</keyword>
  <keyword>sweating</keyword>
  <keyword>underarm</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03024255/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03024255/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BBI-4000 Gel, 5%</title>
          <description>BBI-4000 gel, 5% applied once to each axilla daily</description>
        </group>
        <group group_id="P2">
          <title>BBI-4000 Gel, 10%</title>
          <description>BBI-4000 gel, 10% applied once to each axilla daily</description>
        </group>
        <group group_id="P3">
          <title>BBI-4000 Gel, 15%</title>
          <description>BBI-4000 gel, 15% applied once to each axilla daily</description>
        </group>
        <group group_id="P4">
          <title>Vehicle</title>
          <description>Vehicle (Placebo), applied once to each axilla daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="45"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population includes all subjects randomized in the study who received study drug at least once. Treatment group assignment was based on the treatment actually received. Two participants were randomized to BBI-4000 gel, 15% but were not dispensed the medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Vehicle</title>
          <description>Vehicle (Placebo), administered to each axilla once daily</description>
        </group>
        <group group_id="B2">
          <title>BBI-4000 Gel, 5%</title>
          <description>BBI-4000 gel, 5% administered to each axilla once daily</description>
        </group>
        <group group_id="B3">
          <title>BBI-4000 Gel, 10%</title>
          <description>BBI-4000 gel, 10% administered to each axilla once daily</description>
        </group>
        <group group_id="B4">
          <title>BBI-4000 Gel, 15%</title>
          <description>BBI-4000 gel, 15% administered to each axilla once daily</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="57"/>
            <count group_id="B3" value="57"/>
            <count group_id="B4" value="54"/>
            <count group_id="B5" value="225"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.0" spread="8.62"/>
                    <measurement group_id="B2" value="30.8" spread="10.22"/>
                    <measurement group_id="B3" value="33.7" spread="11.29"/>
                    <measurement group_id="B4" value="30.7" spread="9.24"/>
                    <measurement group_id="B5" value="31.3" spread="9.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Subjects reporting more than one race were originally included in all relevant race categories. Percentages added up to &gt;100%. For this table, subjects reporting more than one race were categorized only into &quot;More Than One Race&quot;.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="174"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy</title>
        <description>11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).&#xD;
The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax</description>
        <time_frame>overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (Placebo), applied to each axilla once daily</description>
          </group>
          <group group_id="O2">
            <title>BBI-4000 Gel, 5%</title>
            <description>BBBI-4000 Sofpironium Bromide Gel, 5% applied to each axilla once daily</description>
          </group>
          <group group_id="O3">
            <title>BBI-4000 Gel, 10%</title>
            <description>BBBI-4000 Sofpironium Bromide Gel, 10% applied to each axilla once daily</description>
          </group>
          <group group_id="O4">
            <title>BBI-4000 Gel, 15%</title>
            <description>BBBI-4000 Sofpironium Bromide Gel, 15% applied to each axilla once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy</title>
          <description>11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).&#xD;
The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax</description>
          <population>mITT Population</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="50"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.30" spread="0.136"/>
                    <measurement group_id="O2" value="-2.02" spread="0.135"/>
                    <measurement group_id="O3" value="-2.09" spread="0.137"/>
                    <measurement group_id="O4" value="-2.10" spread="0.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity</title>
        <description>Subjects reporting more than one adverse event are counted only once using the highest severity.</description>
        <time_frame>Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)</time_frame>
        <population>Number (%) of Subjects Reporting at Least One: TEAE n(%), Safety Population: Vehicle (N=57), BBI-4000 5% (N=57), BBI-4000 10% (N=57), BBI-4000 15% (N=54)</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (Placebo), applied once to each axilla daily</description>
          </group>
          <group group_id="O2">
            <title>BBI-4000 Gel, 5%</title>
            <description>BBBI-4000 Sofpironium Bromide Gel, 5% applied to each axilla once daily</description>
          </group>
          <group group_id="O3">
            <title>BBI-4000 Gel, 10%</title>
            <description>BBI-4000 Sofpironium Bromide Gel, 10% applied to each axilla once daily</description>
          </group>
          <group group_id="O4">
            <title>BBI-4000 Gel, 15%</title>
            <description>BBI-4000 Sofpironium Bromide Gel, 15% applied to each axilla once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity</title>
          <description>Subjects reporting more than one adverse event are counted only once using the highest severity.</description>
          <population>Number (%) of Subjects Reporting at Least One: TEAE n(%), Safety Population: Vehicle (N=57), BBI-4000 5% (N=57), BBI-4000 10% (N=57), BBI-4000 15% (N=54)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population</title>
        <description>Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed.&#xD;
Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.</description>
        <time_frame>Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57</time_frame>
        <population>Overall number of participants analyzed includes those who were compliant with the protocol. Compliance with the protocol per visit at Visits 2-4 (Days -21 to -7), Baseline Visit (Day 1), and Days 8, 15, 22, 29, 36, 41, 42, 43, and 57, affected the number of participants analyzed at these timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Vehicle</title>
            <description>Vehicle (Placebo) Applied to each axilla once daily</description>
          </group>
          <group group_id="O2">
            <title>BBI-4000 Gel 5%</title>
            <description>BBI-4000 Sofpironium Bromide Gel 5% applied to each axilla once daily</description>
          </group>
          <group group_id="O3">
            <title>BBI-4000 Gel 10%</title>
            <description>BBI-4000 Sofipironium Bromide Gel 10% applied to each axilla once daily</description>
          </group>
          <group group_id="O4">
            <title>BBI-4000 Gel 15%</title>
            <description>BBI-4000 Sofpironium Bromide Gel 15% applied to each axilla once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population</title>
          <description>Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed.&#xD;
Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.</description>
          <population>Overall number of participants analyzed includes those who were compliant with the protocol. Compliance with the protocol per visit at Visits 2-4 (Days -21 to -7), Baseline Visit (Day 1), and Days 8, 15, 22, 29, 36, 41, 42, 43, and 57, affected the number of participants analyzed at these timepoints.</population>
          <units>Combined Axilla GSP (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Both axilla combined total</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="44"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Both axilla combined total</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="98"/>
                <count group_id="O3" value="94"/>
                <count group_id="O4" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259.53" spread="141.738"/>
                    <measurement group_id="O2" value="282.41" spread="201.920"/>
                    <measurement group_id="O3" value="281.63" spread="211.542"/>
                    <measurement group_id="O4" value="316.39" spread="201.478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="47"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.36" spread="144.104"/>
                    <measurement group_id="O2" value="124.94" spread="199.072"/>
                    <measurement group_id="O3" value="113.77" spread="119.233"/>
                    <measurement group_id="O4" value="118.49" spread="129.393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="45"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.50" spread="100.171"/>
                    <measurement group_id="O2" value="114.24" spread="175.195"/>
                    <measurement group_id="O3" value="114.07" spread="169.784"/>
                    <measurement group_id="O4" value="106.68" spread="121.225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.10" spread="153.886"/>
                    <measurement group_id="O2" value="102.43" spread="213.006"/>
                    <measurement group_id="O3" value="112.34" spread="128.033"/>
                    <measurement group_id="O4" value="90.48" spread="98.380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="41"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.12" spread="91.999"/>
                    <measurement group_id="O2" value="106.06" spread="180.981"/>
                    <measurement group_id="O3" value="168.13" spread="230.825"/>
                    <measurement group_id="O4" value="117.60" spread="135.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="46"/>
                    <count group_id="O3" value="46"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.87" spread="156.561"/>
                    <measurement group_id="O2" value="105.16" spread="200.641"/>
                    <measurement group_id="O3" value="124.33" spread="147.519"/>
                    <measurement group_id="O4" value="126.44" spread="231.723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 41</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.61" spread="132.620"/>
                    <measurement group_id="O2" value="119.00" spread="195.636"/>
                    <measurement group_id="O3" value="117.85" spread="141.070"/>
                    <measurement group_id="O4" value="93.21" spread="131.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.96" spread="161.590"/>
                    <measurement group_id="O2" value="95.09" spread="157.573"/>
                    <measurement group_id="O3" value="111.98" spread="140.927"/>
                    <measurement group_id="O4" value="88.62" spread="103.408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.13" spread="157.113"/>
                    <measurement group_id="O2" value="139.65" spread="291.857"/>
                    <measurement group_id="O3" value="105.03" spread="108.026"/>
                    <measurement group_id="O4" value="117.34" spread="159.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="49"/>
                    <count group_id="O3" value="47"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
                <analyzed>
                  <units>Both axilla combined total</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.43" spread="193.565"/>
                    <measurement group_id="O2" value="112.09" spread="181.185"/>
                    <measurement group_id="O3" value="177.62" spread="242.634"/>
                    <measurement group_id="O4" value="135.76" spread="165.620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-Emergent Adverse Events (TEAEs) were collected from during investigational treatment Days 1 to 42. A safety follow-up assessment including of TEAEs was also performed ~14 days post end of treatment. A total of 225 subjects were included in the Safety population (54 subjects in the 15% group; and 57 subjects each in the 10%, 5%, and vehicle groups).</time_frame>
      <desc>Treatment-Emergent Adverse Events by System Organ Class and Preferred Term (Safety Population)</desc>
      <group_list>
        <group group_id="E1">
          <title>Vehicle</title>
          <description>Vehicle (Placebo), applied to each axilla, once daily</description>
        </group>
        <group group_id="E2">
          <title>BBI-4000 Sofpironium Bromide Gel 5%</title>
          <description>BBI-4000 Sofpironium Bromide Gel 5%, applied to each axilla, once daily</description>
        </group>
        <group group_id="E3">
          <title>BBI-4000 Sofpironium Bromide Gel 10%</title>
          <description>BBI-4000 Sofpironium Bromide Gel 10%, applied to each axilla, once daily</description>
        </group>
        <group group_id="E4">
          <title>BBI-4000 Sofpironium Bromide Gel 15%</title>
          <description>BBI-4000 Sofpironium Bromide Gel 15%, applied to each axilla, once daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Staphylococcal osteomyelitis / T8-T9 osteomyelitis/discitis with biopsy positive for streptococcus a</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="28" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Mydriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site erosion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Application site odour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Heliobacter gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Osteomyelitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary hesitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dermal Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Ingrown hair</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="57"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Agreement terms prioritized a multi-center publication at the study end. Should such a publication not be completed, an investigator right to individually publish results of his/her study (limited to his/her site data) was included, if for purely scientific or educational purposes; not for any commercial purposes. PI(s) were to submit draft materials to the Sponsor 60 days prior to Investigator release of individual abstract or manuscript. Additional disclosure restrictions and terms applied .</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anthony Robinson, MS CRNP</name_or_title>
      <organization>Botanix Pharmaceuticals</organization>
      <phone>+1 (445) 300-3403</phone>
      <email>trials@botanixpharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03024255
org study id: BBI-4000-CL-203
nct id: NCT03024255
lead sponsor: 
has dmc: No
This study is being conducted to assess the safety and efficacy of 3 concentrations of
      BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the
      Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with
      Axillary Hyperhidrosis.

      Safety will be assessed through collection of vital signs, adverse events, local skin
      responses, hematology, serum chemistry laboratory testing and urinalysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
time frame: overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.
description: 11 question evaluation tool to assess the effect of BBI-4000 gel, 5%, 10% and 15 % on hyperhidrosis disease severity measures in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).
The mean was derived by taking the total score and dividing by the number of questions answered. A negative LSM reflects a reduction, decrease or measured improvement in HDSM-Ax
measure: Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
time frame: Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)
description: Subjects reporting more than one adverse event are counted only once using the highest severity.
measure: Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population
time frame: Visit 2, 3, and 4 timepoints were reported Days -21 to -7, relative to Visit 5/ Day 1/Baseline, Days 8, 15, 22, 29, 36, 41, 42, 43, and 57
description: Measured weight of the amount of sweat produced by Visit Method of calculating average for Baseline, End of Therapy, and End of Therapy Imputed.
Baseline GSP was defined as the mean of any available Visit 2, Visit 3, and Visit 4 values (occurring Days -21 to -7 relative to Day 1 Baseline) End of Therapy is defined as the mean of any available Day 41, Day 42, and Day 43 values.
arm group label: BBI-4000 gel, 5%
arm group type: Experimental
description: BBI-4000 gel, 5% applied once to each axilla daily
arm group label: BBI-4000 gel, 10%
arm group type: Experimental
description: BBI-4000 gel, 10% applied once to each axilla daily
arm group label: BBI-4000 gel, 15%
arm group type: Experimental
description: BBI-4000 gel, 15% applied once to each axilla daily
arm group label: Vehicle
arm group type: Placebo Comparator
description: Placebo, applied once to each axilla daily
intervention type: Drug
intervention name: BBI-4000 gel, 5%
description: BBI-4000 gel, 5% applied once to each axilla daily
arm group label: BBI-4000 gel, 5%
other name: BBI-4000 Low Concentration
intervention type: Drug
intervention name: BBI-4000 gel, 10%
description: BBI-4000 gel, 10% applied once to each axilla daily
arm group label: BBI-4000 gel, 10%
other name: BBI-4000 Medium Concentration
intervention type: Drug
intervention name: BBI-4000 gel, 15%
description: BBI-4000 gel, 15% applied once to each axilla daily
arm group label: BBI-4000 gel, 15%
other name: BBI-4000 High Concentration
intervention type: Drug
intervention name: Vehicle (Placebo)
description: Placebo, applied once to each axilla daily
arm group label: Vehicle
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Walker, MD PhD
role: Study Director
affiliation: Botanix Pharmaceuticals
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 