A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis

NCT ID: NCT03627468

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2020-01-27

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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.

Detailed Description

This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae.

Subjects will apply the gel once daily at bedtime, to both axillae.

A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.

Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 17 scheduled visits to take place over a 52 week period.

Conditions

Primary Axillary Hyperhidrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gel, 5%

Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks

Group Type: EXPERIMENTAL

Sofpironium Bromide Gel, 5%

Intervention Type: DRUG

Sofpironium Bromide Gel, 5%

Gel, 15%

Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks

Group Type: EXPERIMENTAL

Sofpironium Bromide Gel, 15%

Intervention Type: DRUG

Sofpironium Bromide Gel, 15%

Interventions

Sofpironium Bromide Gel, 5%

Sofpironium Bromide Gel, 5%

Intervention Type: DRUG

Sofpironium Bromide Gel, 15%

Sofpironium Bromide Gel, 15%

Intervention Type: DRUG

Other Intervention Names

BBI-4000; BBI-4000

Eligibility Criteria

Inclusion Criteria

• Male or female subject ≥9 years of age in good general health.
• Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 3 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6 months' duration prior to Baseline Visit (Visit 2).

Exclusion Criteria

• In the Investigator's opinion, any skin or subcutaneous tissue conditions of the axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts, significant scarring or open wounds).
• Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the axillary area within 6 months of the Baseline Visit (Visit 2). (b) Axillary thermolysis, sympathectomy or surgical procedures of the axillary area at any time in the past. (c) Serotonergic agonist (or drugs that increase serotonin activity including SSRIs), beta-blocker, alpha-adrenergic agonist (clonidine), dopamine partial agonist or tricyclic antidepressant treatment within 28 days of the Baseline Visit (Visit 2). However, if a subject has been on a stable dose (in the opinion of the PI) of any of these medications and has not had a recent change in hyperhidrosis frequency or severity for 3 months prior to the Baseline Visit; they may be included. Doses of these agents should not be altered during the course of the study. (d) Any topical treatment for hyperhidrosis, requiring a prescription, within 15 days of Baseline Visit (Visit 2).
• 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 (e.g., IV, oral, inhaled, topical) within 28 days of the Baseline Visit (Visit 2).
• Use of potent oral inhibitors of cytochrome P450 CYP3A & CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to the Baseline Visit (Visit 2). The use of topical antifungal medications is permitted if not applied in the treatment area.
• Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such as sage tablets, chamomile, valerian root and St. John's Wort) within 7 days of the Baseline Visit (Visit 2).
• Use of any cholinergic drug (e.g., bethanechol) within 15 days of the Baseline Visit (Visit 2).
• Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with known anticholinergic side effects is prohibited with the following exceptions: (a) If a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and has not had a recent change in hyperhidrosis frequency or severity for 3 months; they may be included. (b) An amphetamine product may be allowed if the dose has been stable for greater than or equal to 6 months without change in hyperhidrosis frequency or severity. (c) Drugs with known anticholinergic side effects (taken within the last 28 days), including dry mouth, blurred vision, may be allowed based on the Principal Investigator's assessment.

NOTE: If anticholinergic side effect(s) are experienced on these medications prior to starting study medication; document the side effect(s) and severities in the source document and the eCRF. The doses of these agents should not be altered during the course of the study.

• Known causes 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 hyperhidrosis symptoms initiated or exacerbated with menopause.
• Subjects with unstable type 1 or type 2 diabetes mellitus or thyroid disease, history of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat production or may be exacerbated by the use of anticholinergics in the Investigator's opinion.
• 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.
• Participating in a study of or used an investigational drug or device within 28 days prior to the Baseline Visit (Visit 2).
• Any major illness within 28 days before the screening examination.
• Any other condition, including psychiatric illness (depression and/or anxiety) that would interfere with study participation and/or evaluation of study endpoints or laboratory abnormality that, in the opinion of the Investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
• History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 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

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, United States

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Skin Care Research, Inc.

Boca Raton, Florida, United States

Baumann Cosmetic & Research Institute

Miami, Florida, United States

Tory Sullivan MD PA

North Miami Beach, Florida, United States

Research Institute of the Southeast, LLC

West Palm Beach, Florida, United States

Grekin Skin Institute

Warren, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

J&S Studies, Inc.

College Station, Texas, United States

Austin Institute for Clinical Research

Pflugerville, Texas, 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-303

Identifier Type: -

Identifier Source: org_study_id