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

NCT03948646 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BBI-4000-CL-302
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 42

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.

Conditions

Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment

  Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment \[6 weeks\] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).

  Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.

• Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment

  Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right +left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment \[6 weeks\] minus ranked GSP at baseline) was used as the outcome value.

  Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.

Study Arms (2)

Active

EXPERIMENTAL

Sofpironium bromide, 15% gel, once per day

Drug: Sofpironium Bromide, 15%

Vehicle

PLACEBO COMPARATOR

Vehicle gel, once per day

Drug: Vehicle

Interventions

Sofpironium Bromide, 15% DRUG

Active

Also known as: BBI-4000, 15%

Active

Vehicle DRUG

Vehicle gel

Also known as: BBI-4000, 0%

Vehicle

Eligibility Criteria

• Age: 9 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (42)

Cahaba Dermatology Skin & Health Center

Birmingham, Alabama, 35244, United States

Location

Advanced Research Associates

Glendale, Arizona, 85308, United States

Location

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

CoDerm Research

Centennial, Colorado, 80111, United States

Location

Colorado Medical Research Center

Denver, Colorado, 80210, United States

Location

CCD Research, PLLC

Cromwell, Connecticut, 06416, United States

Location

The GW Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Driven Research, LLC

Coral Gables, Florida, 33134, United States

Location

Florida Academic Dermatology Centers Research & Education, LLC

Coral Gables, Florida, 33134, United States

Location

GSI Clinical Research

Margate, Florida, 33063, United States

Location

Cordova Research Institute

Miami, Florida, 33155, United States

Location

MOORE Clinical Research, Inc.

Tampa, Florida, 33609, United States

Location

Advanced Medical Research PC

Sandy Springs, Georgia, 30328, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Heartland Research Asssociates - AMR Company

Wichita, Kansas, 67205, United States

Location

Delricht Research

Baton Rouge, Louisiana, 70809, United States

Location

DelRicht Research

New Orleans, Louisiana, 70116, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

Location

DermAssociates

Rockville, Maryland, 20850, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 02472, United States

Location

Michigan Center for Skin Care Research

Clinton Township, Michigan, 48038, United States

Location

Hamzavi Dermatology, Inc.

Fort Gratiot, Michigan, 48059, United States

Location

Saint Louis University, Department of Dermatology

St Louis, Missouri, 63122, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

JDR Dermatology Research

Las Vegas, Nevada, 89148, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

SkinSearch of Rochester

Rochester, New York, 14623, United States

Location

Dermatology, Laser and Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Aventiv Research Inc.

Dublin, Ohio, 43016, United States

Location

Yardley Dermatology Associates, PC

Morrisville, Pennsylvania, 19067, United States

Location

Westlake Dermatology & Cosmetic Surgery

Austin, Texas, 78746, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Suzanne Bruce and Associates, P.A.

Houston, Texas, 77056, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Center for Clinical Studies, LTD.LLP

Webster, Texas, 77598, United States

Location

Valley Dermatology and Skin Cancer Center

Spokane, Washington, 99216, United States

Location

Results Point of Contact

• Title: Anthony Robinson MS 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: December 4, 2020
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (42)