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

NCT03836287 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BBI-4000-CL-301
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 39

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 Gel, 15%

Vehicle

PLACEBO COMPARATOR

Vehicle gel, once per day

Drug: Vehicle

Interventions

Sofpironium Bromide Gel, 15% DRUG

Active

Also known as: BBI-4000 Gel, 15%

Active

Vehicle DRUG

Vehicle gel

Also known as: BBI-4000 Gel, 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 (39)

Total Skin and Beauty Dermatology Center, P.C.

Birmingham, Alabama, 35205, United States

Location

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

California Dermatology & Clinical Research Institute

Encinitas, California, 92007, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

AboutSkin Research, LLC

Greenwood Village, Colorado, 80111, United States

Location

Center for Clinical & Cosmetic Research

Aventura, Florida, 33180, United States

Location

Skin Care Research, LLC

Boca Raton, Florida, 33486, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

Finlay Medical Research

Greenacres City, Florida, 33467, United States

Location

Aby's New Generation Research

Hialeah, Florida, 33016, United States

Location

Baumann Cosmetic and Research Institute

Miami, Florida, 33137, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

My Community Research Center, Inc.

Miami, Florida, 33155, United States

Location

Tory Sullivan, MD PA

North Miami Beach, Florida, 33162, United States

Location

Research Institute of the Southeast

West Palm Beach, Florida, 33401, United States

Location

Dawes Fretzin Research Group

Indianapolis, Indiana, 46250, United States

Location

Maryland Laser Skin and Vein

Hunt Valley, Maryland, 21030, United States

Location

Lawrence J Green, MD LLC

Rockville, Maryland, 20850, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Skin Specialists, P.C.

Omaha, Nebraska, 68144, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

DermResearch Center of New York, Inc.

Stony Brook, New York, 11790, United States

Location

PMG Research of Cary

Raleigh, North Carolina, 27518, United States

Location

Haber Dermatology and Cosmetic Surgery, Inc.

Beachwood, Ohio, 44122, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29414, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Dermatology Associates of Seattle

Seattle, Washington, 98101, 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: February 6, 2019
• First Posted: February 11, 2019
• Study Start: October 9, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)