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

NCT03627468 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BBI-4000-CL-303
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 12

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.

Conditions

Primary Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity

  The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe

  All safety subjects, reaching week 48 or not

• Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)

  Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.

  All Safety Subject, Baseline-Through study completion (48 weeks) or Not

Secondary Outcomes (3)

• The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score

  From baseline to each visit through study completion (48 weeks)

• The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score

  From baseline to each visit through study completion (48 weeks)

• The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score

  From baseline to each visit through study completion (48 weeks)

Study Arms (2)

Gel, 5%

EXPERIMENTAL

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

Drug: Sofpironium Bromide Gel, 5%

Gel, 15%

EXPERIMENTAL

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

Drug: Sofpironium Bromide Gel, 15%

Interventions

Sofpironium Bromide Gel, 5% DRUG

Sofpironium Bromide Gel, 5%

Also known as: BBI-4000

Gel, 5%

Sofpironium Bromide Gel, 15% DRUG

Sofpironium Bromide Gel, 15%

Also known as: BBI-4000

Gel, 15%

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (12)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Baumann Cosmetic & Research Institute

Miami, Florida, 33137, United States

Location

Tory Sullivan MD PA

North Miami Beach, Florida, 33162, United States

Location

Research Institute of the Southeast, LLC

West Palm Beach, Florida, 33401, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Results Point of Contact

• Title: Anthony Robinson, MS, MBA, CRNP
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Study Officials

• Patricia Walker, MD PhD

  Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 13, 2018
• Study Start: September 5, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)