Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)

NCT ID: NCT03948646

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2021-08-13

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, 15%

Intervention Type: DRUG

Active

Vehicle

Vehicle gel, once per day

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle gel

Interventions

Sofpironium Bromide, 15%

Active

Intervention Type: DRUG

Vehicle

Vehicle gel

Intervention Type: DRUG

Other Intervention Names

BBI-4000, 15%; BBI-4000, 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

Cahaba Dermatology Skin & Health Center

Birmingham, Alabama, United States

Advanced Research Associates

Glendale, Arizona, United States

Arkansas Research Trials

North Little Rock, Arkansas, United States

First OC Dermatology

Fountain Valley, California, United States

CoDerm Research

Centennial, Colorado, United States

Colorado Medical Research Center

Denver, Colorado, United States

CCD Research, PLLC

Cromwell, Connecticut, United States

The GW Medical Faculty Associates

Washington D.C., District of Columbia, United States

Driven Research, LLC

Coral Gables, Florida, United States

Florida Academic Dermatology Centers Research & Education, LLC

Coral Gables, Florida, United States

GSI Clinical Research

Margate, Florida, United States

Cordova Research Institute

Miami, Florida, United States

MOORE Clinical Research, Inc.

Tampa, Florida, United States

Advanced Medical Research PC

Sandy Springs, Georgia, United States

DeNova Research

Chicago, Illinois, United States

Qualmedica Research, LLC

Evansville, Indiana, United States

Heartland Research Asssociates - AMR Company

Wichita, Kansas, United States

Delricht Research

Baton Rouge, Louisiana, United States

DelRicht Research

New Orleans, Louisiana, United States

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, United States

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, United States

DermAssociates

Rockville, Maryland, United States

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, United States

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Hamzavi Dermatology, Inc.

Fort Gratiot, Michigan, United States

Saint Louis University, Department of Dermatology

St Louis, Missouri, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

JDR Dermatology Research

Las Vegas, Nevada, United States

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

SkinSearch of Rochester

Rochester, New York, United States

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, United States

Aventiv Research Inc.

Dublin, Ohio, United States

Yardley Dermatology Associates, PC

Morrisville, Pennsylvania, United States

Westlake Dermatology & Cosmetic Surgery

Austin, Texas, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

J&S Studies, Inc.

College Station, Texas, United States

Modern Research Associates

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Suzanne Bruce and Associates, P.A.

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Center for Clinical Studies, LTD.LLP

Webster, Texas, United States

Valley Dermatology and Skin Cancer Center

Spokane, 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-302

Identifier Type: -

Identifier Source: org_study_id