Psoriasis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

351

Study ID:

NCT03948646

Recruitment Status:

Completed

Sponsor:

Botanix Pharmaceuticals

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There are 41 Locations for this study

See Locations Near You

Cahaba Dermatology Skin & Health Center
Birmingham Alabama, 35244, United States
Advanced Research Associates
Glendale Arizona, 85308, United States
Arkansas Research Trials
North Little Rock Arkansas, 72117, United States
First OC Dermatology
Fountain Valley California, 92708, United States
CoDerm Research
Centennial Colorado, 80111, United States
Colorado Medical Research Center
Denver Colorado, 80210, United States
CCD Research, PLLC
Cromwell Connecticut, 06416, United States
The GW Medical Faculty Associates
Washington District of Columbia, 20037, United States
Driven Research, LLC
Coral Gables Florida, 33134, United States
Florida Academic Dermatology Centers Research & Education, LLC
Coral Gables Florida, 33134, United States
GSI Clinical Research
Margate Florida, 33063, United States
Cordova Research Institute
Miami Florida, 33155, United States
MOORE Clinical Research, Inc.
Tampa Florida, 33609, United States
Advanced Medical Research PC
Sandy Springs Georgia, 30328, United States
DeNova Research
Chicago Illinois, 60611, United States
Qualmedica Research, LLC
Evansville Indiana, 47715, United States
Heartland Research Asssociates - AMR Company
Wichita Kansas, 67205, United States
Delricht Research
Baton Rouge Louisiana, 70809, United States
DelRicht Research
New Orleans Louisiana, 70116, United States
Lupo Center for Aesthetic and General Dermatology
New Orleans Louisiana, 70124, United States
Etre, Cosmetic Dermatology and Laser Center
New Orleans Louisiana, 70130, United States
DermAssociates
Rockville Maryland, 20850, United States
Bay State Clinical Trials, Inc.
Watertown Massachusetts, 02472, United States
Michigan Center for Skin Care Research
Clinton Township Michigan, 48038, United States
Hamzavi Dermatology, Inc.
Fort Gratiot Michigan, 48059, United States
Saint Louis University, Department of Dermatology
Saint Louis Missouri, 63122, United States
Meridian Clinical Research, LLC
Omaha Nebraska, 68134, United States
JDR Dermatology Research
Las Vegas Nevada, 89148, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
SkinSearch of Rochester
Rochester New York, 14623, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte North Carolina, 28207, United States
Aventiv Research Inc.
Dublin Ohio, 43016, United States
Yardley Dermatology Associates, PC
Morrisville Pennsylvania, 19067, United States
Westlake Dermatology & Cosmetic Surgery
Austin Texas, 78746, United States
Bellaire Dermatology Associates
Bellaire Texas, 77401, United States
J&S Studies, Inc.
College Station Texas, 77845, United States
Modern Research Associates
Dallas Texas, 75231, United States
University of Texas Health Science Center at Houston
Houston Texas, 77030, United States
Suzanne Bruce and Associates, P.A.
Houston Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
Center for Clinical Studies, LTD.LLP
Webster Texas, 77598, United States
Valley Dermatology and Skin Cancer Center
Spokane Washington, 99216, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

351

Study ID:

NCT03948646

Recruitment Status:

Completed

Sponsor:


Botanix Pharmaceuticals

How clear is this clinincal trial information?

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