<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/NCT03836287</url>
  </required_header>
  <id_info>
    <org_study_id>BBI-4000-CL-301</org_study_id>
    <nct_id>NCT03836287</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)</brief_title>
  <acronym>Cardigan I</acronym>
  <official_title>A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% 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>
    <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.&#xD;
&#xD;
      Current therapies have limited effectiveness, significant side effects, and can be invasive&#xD;
      and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the&#xD;
      topical treatment of hyperhidrosis.&#xD;
&#xD;
      This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus&#xD;
      vehicle (2 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 topically applied sofpironium bromide, 15% gel 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;
&#xD;
      A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15%&#xD;
      or vehicle.&#xD;
&#xD;
      Adverse events, vital signs, and local tolerability assessments will be collected at visits&#xD;
      across the study. Urine pregnancy tests will be taken throughout the course of the study for&#xD;
      women of child bearing potential. Blood and urine samples will be collected and analyzed for&#xD;
      routine hematology, chemistry, and urinalysis parameters at specified visits.&#xD;
      Patient-reported outcome assessments will be recorded during the study at predefined time&#xD;
      points.&#xD;
&#xD;
      The study will be comprised of a total of 13 scheduled visits to take place over&#xD;
      approximately 11 to 15 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Actual">June 25, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2021</primary_completion_date>
  <phase>Phase 3</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>The number of participants with treatment emergent adverse events</measure>
    <time_frame>Through study completion (6 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>Change in Hyperhidrosis Disease Severity Measure-Axillary score</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gravimetric sweat production</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in the measured weight (mg) of axillary (right+left axillae) sweat production from baseline to end of study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Axillary Hyperhidrosis</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sofpironium bromide, 15% gel, once per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle gel, once per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofpironium Bromide Gel, 15%</intervention_name>
    <description>Active</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>BBI-4000 Gel, 15%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle gel</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>BBI-4000 Gel, 0%; Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject ≥ 9 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 and&#xD;
             (c) a minimum GSP of 50 mg in each axilla with a combined total of 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(e).&#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 any cholinergic drug (e.g. bethanechol) within 28 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 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>
  <location>
    <facility>
      <name>Total Skin and Beauty Dermatology Center, P.C.</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigate MD, LLC</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>California Dermatology &amp; Clinical Research Institute</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Therapeutics Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Science Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AboutSkin Research, LLC</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical &amp; Cosmetic Research</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Care Research, LLC</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Research Institute</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Finlay Medical Research</name>
      <address>
        <city>Greenacres City</city>
        <state>Florida</state>
        <zip>33467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aby's New Generation Research</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baumann Cosmetic and Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Dermatology Research, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>My Community Research Center, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tory Sullivan, MD PA</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the Southeast</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Research Group</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Laser Skin and Vein</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence J Green, MD LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinCare Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grekin Skin Institute</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>New Brighton</city>
        <state>Minnesota</state>
        <zip>55112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSearch Clinical Trials</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Specialists, P.C.</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch Center of New York, Inc.</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Cary</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haber Dermatology and Cosmetic Surgery, Inc.</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Dermatology &amp; Research Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of the Carolinas</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research, Inc.</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Dermatology and Laser Specialists</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Associates of Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <disposition_first_submitted>January 21, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>January 21, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 25, 2022</disposition_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 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>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03836287
org study id: BBI-4000-CL-301
nct id: NCT03836287
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.

      Current therapies have limited effectiveness, significant side effects, and can be invasive
      and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the
      topical treatment of hyperhidrosis.

      This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus
      vehicle (2 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 topically applied sofpironium bromide, 15% gel 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.

      A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15%
      or vehicle.

      Adverse events, vital signs, and local tolerability assessments will be collected at visits
      across the study. 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
      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 13 scheduled visits to take place over
      approximately 11 to 15 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The number of participants with treatment emergent adverse events
time frame: Through study completion (6 weeks).
description: Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe
measure: Change in Hyperhidrosis Disease Severity Measure-Axillary score
time frame: 6 weeks
description: Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).
measure: Gravimetric sweat production
time frame: 6 weeks
description: Change in the measured weight (mg) of axillary (right+left axillae) sweat production from baseline to end of study.
arm group label: Active
arm group type: Experimental
description: Sofpironium bromide, 15% gel, once per day
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle gel, once per day
intervention type: Drug
intervention name: Sofpironium Bromide Gel, 15%
description: Active
arm group label: Active
other name: BBI-4000 Gel, 15%
intervention type: Drug
intervention name: Vehicle
description: Vehicle gel
arm group label: Vehicle
other name: BBI-4000 Gel, 0%; Placebo
criteria: 
gender: All
minimum age: 9 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Walker, MD PhD
role: Study Director
affiliation: Botanix Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Hyperhidrosis
mesh term: Bromides
sharing ipd: No