Clinical trial NCT03836287: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
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: 2019-02-11
Enrollment: 350
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: Total Skin and Beauty Dermatology Center, P.C.
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD, LLC
state: Arizona
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Aventura
country: United States
facility: Center for Clinical & Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research
state: Florida
city: Hialeah
country: United States
facility: Aby's New Generation Research
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Miami
country: United States
facility: My Community Research Center, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD PA
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Research Group
state: Indiana
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein
state: Maryland
city: Rockville
country: United States
facility: Lawrence J Green, MD LLC
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc.
state: New York
city: Raleigh
country: United States
facility: PMG Research of Cary
state: North Carolina
city: Beachwood
country: United States
facility: Haber Dermatology and Cosmetic Surgery, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
Study officials:
affiliation: Botanix Pharmaceuticals
name: Patricia Walker, MD PhD
role: STUDY_DIRECTOR
References: