Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (Cardigan I)

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

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.

Study Overview

• Status: Completed
• Conditions: Axillary Hyperhidrosis
• Intervention / Treatment: Drug: Vehicle; Drug: Sofpironium Bromide Gel, 15%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, P.C.
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD, LLC
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center
  • California
    • Encinitas, California, United States, 92007
      • California Dermatology & Clinical Research Institute
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Research, LLC
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical & Cosmetic Research
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Llc
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Hialeah, Florida, United States, 33016
      • Aby's New Generation Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
    • Miami, Florida, United States, 33155
      • My Community Research Center, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Tory Sullivan, Md Pa
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the Southeast
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Research Group
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Laser Skin and Vein
    • Rockville, Maryland, United States, 20850
      • Lawrence J Green, MD LLC
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, P.C.
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York, Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27518
      • PMG Research of Cary
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Haber Dermatology and Cosmetic Surgery, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subject ≥ 9 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 and (c) a minimum GSP of 50 mg in 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(e).
• 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 any cholinergic drug (e.g. bethanechol) within 28 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Sofpironium bromide, 15% gel, once per day	Drug: Sofpironium Bromide Gel, 15%; Active; Other Names: BBI-4000 Gel, 15%
Placebo Comparator: Vehicle; Vehicle gel, once per day	Drug: Vehicle; Vehicle gel; Other Names: BBI-4000 Gel, 0%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with treatment emergent adverse events	Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe	Through study completion (6 weeks).
Change in Hyperhidrosis Disease Severity Measure-Axillary score	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]).	6 weeks
Gravimetric sweat production	Change in the measured weight (mg) of axillary (right+left axillae) sweat production from baseline to end of study.	6 weeks

Collaborators and Investigators

• Sponsor: Botanix Pharmaceuticals
• Investigators: Study Director: Patricia Walker, MD PhD, Botanix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): June 25, 2021
• Study Completion (Actual): June 25, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Anticonvulsants; Bromides
• Other Study ID Numbers: BBI-4000-CL-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No