Clinical trial NCT03948646: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axillary Hyperhidrosis
Lead sponsor: Botanix Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-05-14
Enrollment: 351
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.

A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.

Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. 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 13 scheduled visits to take place over approximately 11 to 15 weeks.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: 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.
measure: Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology Skin & Health Center
state: Alabama
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Centennial
country: United States
facility: CoDerm Research
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: Cromwell
country: United States
facility: CCD Research, PLLC
state: Connecticut
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
city: Coral Gables
country: United States
facility: Driven Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers Research & Education, LLC
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Asssociates - AMR Company
state: Kansas
city: Baton Rouge
country: United States
facility: Delricht Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: Lupo Center for Aesthetic and General Dermatology
state: Louisiana
city: New Orleans
country: United States
facility: Etre, Cosmetic Dermatology and Laser Center
state: Louisiana
city: Rockville
country: United States
facility: DermAssociates
state: Maryland
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Clinton Township
country: United States
facility: Michigan Center for Skin Care Research
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University, Department of Dermatology
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Rochester
country: United States
facility: SkinSearch of Rochester
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Morrisville
country: United States
facility: Yardley Dermatology Associates, PC
state: Pennsylvania
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies, LTD.LLP
state: Texas
city: Spokane
country: United States
facility: Valley Dermatology and Skin Cancer Center
state: Washington
Study officials:
affiliation: Botanix Pharmaceuticals
name: Patricia Walker, MD PhD
role: STUDY_DIRECTOR
References: