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A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BBI-4000 gel, 5%
BBI-4000 gel, 10%
BBI-4000 gel, 15%
Vehicle (Placebo)
Sponsored by
Botanix Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring sweat gland disease, sweating, underarm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subject ≥ 18 years of age.
  • Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.
  • The ability to understand and follow all study-related procedures including study drug administration.
  • Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.

Exclusion Criteria:

  • In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s).
  • Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
  • Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
  • Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6.
  • Use of any cholinergic drug (e.g. bethanechol) within 30 days.
  • Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
  • Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion.
  • Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
  • Subject is pregnant, lactating or is planning to become pregnant during the study.
  • History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    BBI-4000 gel, 5%

    BBI-4000 gel, 10%

    BBI-4000 gel, 15%

    Vehicle

    Arm Description

    BBI-4000 gel, 5% applied once to each axilla daily

    BBI-4000 gel, 10% applied once to each axilla daily

    BBI-4000 gel, 15% applied once to each axilla daily

    Placebo, applied once to each axilla daily

    Outcomes

    Primary Outcome Measures

    Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
    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
    Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
    Subjects reporting more than one adverse event are counted only once using the highest severity.

    Secondary Outcome Measures

    Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population
    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.

    Full Information

    First Posted
    January 6, 2017
    Last Updated
    April 20, 2023
    Sponsor
    Botanix Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03024255
    Brief Title
    A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 22, 2016 (Actual)
    Primary Completion Date
    September 19, 2017 (Actual)
    Study Completion Date
    September 19, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Botanix Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperhidrosis
    Keywords
    sweat gland disease, sweating, underarm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    227 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BBI-4000 gel, 5%
    Arm Type
    Experimental
    Arm Description
    BBI-4000 gel, 5% applied once to each axilla daily
    Arm Title
    BBI-4000 gel, 10%
    Arm Type
    Experimental
    Arm Description
    BBI-4000 gel, 10% applied once to each axilla daily
    Arm Title
    BBI-4000 gel, 15%
    Arm Type
    Experimental
    Arm Description
    BBI-4000 gel, 15% applied once to each axilla daily
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, applied once to each axilla daily
    Intervention Type
    Drug
    Intervention Name(s)
    BBI-4000 gel, 5%
    Other Intervention Name(s)
    BBI-4000 Low Concentration
    Intervention Description
    BBI-4000 gel, 5% applied once to each axilla daily
    Intervention Type
    Drug
    Intervention Name(s)
    BBI-4000 gel, 10%
    Other Intervention Name(s)
    BBI-4000 Medium Concentration
    Intervention Description
    BBI-4000 gel, 10% applied once to each axilla daily
    Intervention Type
    Drug
    Intervention Name(s)
    BBI-4000 gel, 15%
    Other Intervention Name(s)
    BBI-4000 High Concentration
    Intervention Description
    BBI-4000 gel, 15% applied once to each axilla daily
    Intervention Type
    Drug
    Intervention Name(s)
    Vehicle (Placebo)
    Other Intervention Name(s)
    Control
    Intervention Description
    Placebo, applied once to each axilla daily
    Primary Outcome Measure Information:
    Title
    Change of Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) Score From Baseline to End of Therapy
    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
    Time Frame
    overall ~6 Weeks, as listed in description includes: Baseline-Visit 1, Visit 4 and End of Therapy Visit - Days 41, 42, 43.
    Title
    Number (%) of Subjects Reporting at Least One Treatment Emergent Adverse Event by Severity
    Description
    Subjects reporting more than one adverse event are counted only once using the highest severity.
    Time Frame
    Treatment initiation through end of treatment (~42 days) and subsequent safety f/u (~14 days following end of treatment)
    Secondary Outcome Measure Information:
    Title
    Average Gravimetrically Measured Sweat Production (GSP) Observed by Visit, Per Protocol Population
    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.
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subject ≥ 18 years of age. Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4, (c) HDSS of 3 or 4 and (d) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg. The ability to understand and follow all study-related procedures including study drug administration. Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product. Exclusion Criteria: In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(s). Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis. Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration. Use of potent inhibitors of cytochrome P450 CYP3A and CYP2D6. Use of any cholinergic drug (e.g. bethanechol) within 30 days. Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.). Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion. Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation. Subject is pregnant, lactating or is planning to become pregnant during the study. History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia Walker, MD PhD
    Organizational Affiliation
    Botanix Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Confirmatory Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis

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