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

NCT ID: NCT03836287

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-09
• Study Completion Date: 2021-06-25

Brief Summary

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.

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.

Conditions

Axillary Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Sofpironium bromide, 15% gel, once per day

Group Type: EXPERIMENTAL

Sofpironium Bromide Gel, 15%

Intervention Type: DRUG

Active

Vehicle

Vehicle gel, once per day

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle gel

Interventions

Sofpironium Bromide Gel, 15%

Active

Intervention Type: DRUG

Vehicle

Vehicle gel

Intervention Type: DRUG

Other Intervention Names

BBI-4000 Gel, 15%; BBI-4000 Gel, 0%

Eligibility Criteria

Inclusion Criteria

• Male or female subject ≥ 9 years of age.
• Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis 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.

• Minimum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Botanix Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Walker, MD PhD

Role: STUDY_DIRECTOR

Botanix Pharmaceuticals

Locations

Total Skin and Beauty Dermatology Center, P.C.

Birmingham, Alabama, United States

Investigate MD, LLC

Scottsdale, Arizona, United States

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

AboutSkin Research, LLC

Greenwood Village, Colorado, United States

Center for Clinical & Cosmetic Research

Aventura, Florida, United States

Skin Care Research, LLC

Boca Raton, Florida, United States

Skin Research Institute

Coral Gables, Florida, United States

Finlay Medical Research

Greenacres City, Florida, United States

Aby's New Generation Research

Hialeah, Florida, United States

Baumann Cosmetic and Research Institute

Miami, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

My Community Research Center, Inc.

Miami, Florida, United States

Tory Sullivan, MD PA

North Miami Beach, Florida, United States

Research Institute of the Southeast

West Palm Beach, Florida, United States

Dawes Fretzin Research Group

Indianapolis, Indiana, United States

Maryland Laser Skin and Vein

Hunt Valley, Maryland, United States

Lawrence J Green, MD LLC

Rockville, Maryland, United States

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Grekin Skin Institute

Warren, Michigan, United States

Minnesota Clinical Study Center

New Brighton, Minnesota, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Skin Specialists, P.C.

Omaha, Nebraska, United States

Hassman Research Institute

Berlin, New Jersey, United States

DermResearch Center of New York, Inc.

Stony Brook, New York, United States

PMG Research of Cary

Raleigh, North Carolina, United States

Haber Dermatology and Cosmetic Surgery, Inc.

Beachwood, Ohio, United States

Oregon Dermatology & Research Center

Portland, Oregon, United States

Clinical Research Center of the Carolinas

Charleston, South Carolina, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

DermResearch, Inc.

Austin, Texas, United States

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dermatology Associates of Seattle

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BBI-4000-CL-301

Identifier Type: -

Identifier Source: org_study_id