<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/NCT03785587</url>
  </required_header>
  <id_info>
    <org_study_id>BBI-4000-CL-108</org_study_id>
    <nct_id>NCT03785587</nct_id>
  </id_info>
  <brief_title>A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis</brief_title>
  <official_title>A Multi-Center Open-Label Extension Study to Assess the Long-Term Safety Tolerability and Pharmacokinetics of Sofpironium Bromide Gel 15% Applied Topically to Children and Adolescents Age 9-17 Years Previously Enrolled in BBI-4000-CL-105</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,&#xD;
      hands, and feet) affects approximately 4.8% of the US population and is believed to be caused&#xD;
      by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is&#xD;
      a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2&#xD;
      study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of&#xD;
      sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, phase 2 long-term study designed to evaluate the safety, local&#xD;
      tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically&#xD;
      to the axillae.&#xD;
&#xD;
      Subjects will apply the gel once daily at bedtime, to both axillae.&#xD;
&#xD;
      A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.&#xD;
&#xD;
      Adverse events, vital signs, and local tolerability assessments will be collected at each&#xD;
      visit. Urine pregnancy tests will be taken throughout the course of the study for women of&#xD;
      child bearing potential. Blood and urine samples will be collected and analyzed for&#xD;
      pharmacokinetics, routine hematology, chemistry, and urinalysis parameters at specified&#xD;
      visits. Patient-reported outcome assessments will be recorded during the study at predefined&#xD;
      time points.&#xD;
&#xD;
      The study will be comprised of a total of 8 scheduled visits to take place over a 26 week&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">September 6, 2019</completion_date>
  <primary_completion_date type="Actual">September 6, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).</measure>
    <time_frame>Through study completion (24 weeks).</time_frame>
    <description>Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.</measure>
    <time_frame>Through study completion (24 weeks).</time_frame>
    <description>Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)</measure>
    <time_frame>Through study completion (24 weeks).</time_frame>
    <description>Trough levels of sofpironium based on sampling schedule.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Primary Axillary Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Gel, 15%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofpironium Bromide Gel, 15%</intervention_name>
    <description>Sofpironium Bromide Gel, 15%</description>
    <arm_group_label>Gel, 15%</arm_group_label>
    <other_name>BBI-4000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject ≥9 to &lt;17 years of age in good general health.&#xD;
&#xD;
          -  Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a)&#xD;
             HDSM-Ax of 2 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit&#xD;
             (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6&#xD;
             months' duration prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In the Investigator's opinion, any skin or subcutaneous tissue conditions of the&#xD;
             axilla(e), (i.e., the axillary area should be deemed otherwise &quot;normal&quot;, besides the&#xD;
             hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts,&#xD;
             significant scarring or open wounds).&#xD;
&#xD;
          -  Prior use of any prohibited medication(s) or procedure(s) within the specified&#xD;
             timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the&#xD;
             axillary area within 9 months of enrollment. (b) Axillary thermolysis, sympathectomy&#xD;
             or surgical procedures of the axillary area at any time in the past. (c) Serotonergic&#xD;
             agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker,&#xD;
             alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic&#xD;
             antidepressant treatment within 30 days of enrollment. However, if a subject has been&#xD;
             on a stable dose (in the opinion of the PI) of any of these medications and has not&#xD;
             had a recent change in hyperhidrosis frequency or severity for 3 months prior to&#xD;
             enrollment; they may be included. Doses of these agents should not be altered during&#xD;
             the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a&#xD;
             prescription, within 3 days of enrollment.&#xD;
&#xD;
          -  Anticholinergic agents [with the exception of sofpironium bromide] used to treat&#xD;
             conditions such as, but not limited to, hyperhidrosis, asthma, incontinence,&#xD;
             gastrointestinal cramps, and muscular spasms by any route of administration (e.g., IV,&#xD;
             oral, inhaled, topical) within 30 days of the enrollment.&#xD;
&#xD;
          -  Use of potent oral inhibitors of cytochrome P450 CYP3A &amp; CYP2D6 and transporter&#xD;
             inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. The use of topical&#xD;
             antifungal medications is permitted if not applied in the treatment area.&#xD;
&#xD;
          -  Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such&#xD;
             as sage tablets, chamomile, valerian root and St. John's Wort) within 14 days of&#xD;
             enrollment.&#xD;
&#xD;
          -  Use of any cholinergic drug (e.g., bethanechol) within 30 days of enrollment.&#xD;
&#xD;
          -  Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with&#xD;
             known anticholinergic side effects is prohibited with the following exceptions: (a) If&#xD;
             a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and&#xD;
             has not had a recent change in hyperhidrosis frequency or severity for 3 months; they&#xD;
             may be included. (b) An amphetamine product may be allowed if the dose has been stable&#xD;
             for greater than or equal to 6 months without change in hyperhidrosis frequency or&#xD;
             severity for 3 months. (c) Drugs with known anticholinergic side effects (taken within&#xD;
             the last 30 days), including dry mouth, blurred vision, may be allowed based on the&#xD;
             Principal Investigator's assessment.&#xD;
&#xD;
          -  Known causes 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 hyperhidrosis symptoms initiated or exacerbated with menopause.&#xD;
&#xD;
          -  Subjects with unstable type 1 or type 2 diabetes mellitus or thyroid disease, history&#xD;
             of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive&#xD;
             or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic&#xD;
             hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's&#xD;
             syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat&#xD;
             production or may be exacerbated by the use of anticholinergics in the Investigator's&#xD;
             opinion.&#xD;
&#xD;
          -  Known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components&#xD;
             of the topical formulation.&#xD;
&#xD;
          -  Subject is pregnant, lactating or is planning to become pregnant during the study.&#xD;
&#xD;
          -  Unable or unwilling to undergo multiple venipunctures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>16 Years</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>
  <location>
    <facility>
      <name>Northwest Arkansas Clinical Trials Center</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <results_first_submitted>December 22, 2022</results_first_submitted>
  <results_first_submitted_qc>February 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 14, 2023</results_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperhidrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
  </intervention_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>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03785587/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>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03785587/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gel, 15%</title>
          <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>Gel, 15%</title>
          <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
          </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="13.3" spread="2.29"/>
                  </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="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).</title>
        <description>Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.</description>
        <time_frame>Through study completion (24 weeks).</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Gel, 15%</title>
            <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).</title>
          <description>Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.</description>
          <population>Safety Population</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="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.</title>
        <description>Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population</description>
        <time_frame>Through study completion (24 weeks).</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Gel, 15% - MINIMAL ASSESSMENT</title>
            <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
          </group>
          <group group_id="O2">
            <title>Gel, 15% - MILD ASSESSMENT</title>
            <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
          </group>
          <group group_id="O3">
            <title>Gel, 15% - MODERATE ASSESSMENT</title>
            <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
          </group>
          <group group_id="O4">
            <title>Gel, 15% - SEVERE ASSESSMENT</title>
            <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.</title>
          <description>Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population</description>
          <population>Safety Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Burning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stinging</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scaling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)</title>
        <description>Trough levels of sofpironium based on sampling schedule.</description>
        <time_frame>Through study completion (24 weeks).</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Concentration Trough (ng/mL) Sofpironium Bromide Gel, 15%</title>
            <description>Concentration Trough (ng/mL) Sofpironium PK Population N=20</description>
          </group>
          <group group_id="O2">
            <title>Concentration Trough (ng/mL) BBI-4010</title>
            <description>Concentration Trough (ng/mL) BBI-4010 PK Population N=20</description>
          </group>
        </group_list>
        <measure>
          <title>The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)</title>
          <description>Trough levels of sofpironium based on sampling schedule.</description>
          <population>PK Population</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12562" spread="0.326157"/>
                    <measurement group_id="O2" value="0.09364" spread="0.264432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24386" spread="0.748205"/>
                    <measurement group_id="O2" value="0.08800" spread="0.203345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04728" spread="0.173893"/>
                    <measurement group_id="O2" value="0.04438" spread="0.177500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>26 Weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gel, 15%</title>
          <description>Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks&#xD;
Sofpironium Bromide Gel, 15%: Sofpironium Bromide Gel, 15%</description>
        </group>
      </group_list>
      <serious_events>
        <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="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.1)</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="7" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mydriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chapped Lips</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </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="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Application Site Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetitie</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning Sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </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="21"/>
              </event>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
              </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/NCT03785587
org study id: BBI-4000-CL-108
nct id: NCT03785587
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
      hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
      by an overactive cholinergic response of the sweat glands. Sofpironium bromide (BBI-4000) is
      a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2
      study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of
      sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.
This is an open-label, phase 2 long-term study designed to evaluate the safety, local
      tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied topically
      to the axillae.

      Subjects will apply the gel once daily at bedtime, to both axillae.

      A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%.

      Adverse events, vital signs, and local tolerability assessments will be collected at each
      visit. Urine pregnancy tests will be taken throughout the course of the study for women of
      child bearing potential. Blood and urine samples will be collected and analyzed for
      pharmacokinetics, routine hematology, chemistry, and urinalysis parameters at specified
      visits. Patient-reported outcome assessments will be recorded during the study at predefined
      time points.

      The study will be comprised of a total of 8 scheduled visits to take place over a 26 week
      period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).
time frame: Through study completion (24 weeks).
description: Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.
measure: The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.
time frame: Through study completion (24 weeks).
description: Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population
measure: The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)
time frame: Through study completion (24 weeks).
description: Trough levels of sofpironium based on sampling schedule.
arm group label: Gel, 15%
arm group type: Experimental
description: Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks
intervention type: Drug
intervention name: Sofpironium Bromide Gel, 15%
description: Sofpironium Bromide Gel, 15%
arm group label: Gel, 15%
other name: BBI-4000
criteria: 
gender: All
minimum age: 9 Years
maximum age: 16 Years
healthy volunteers: No
last name: Patricia Walker, MD PhD
role: Study Director
affiliation: Botanix Pharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis
mesh term: Bromides
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 