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

Completed · Phase 3

Conditions studied: Axillary Hyperhidrosis

In brief

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.

Key facts

Study ID

NCT03948646

Run by

Botanix Pharmaceuticals

People needed

351

Starts

2020-12-04

Expected to finish

2021-08-13

Last updated by the study team

2024-05-21

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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