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

Axillary Hyperhidrosis Clinical Trial

— CARDIGANII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948646
• Other study ID #: BBI-4000-CL-302
• Status: Completed
• Phase: Phase 3
• Start date: December 4, 2020
• Est. completion date: August 13, 2021

Study information

• Verified date: May 2024
• Source: Botanix Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: August 13, 2021
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Axillary Hyperhidrosis
• Hyperhidrosis

Intervention

Drug:
• Sofpironium Bromide, 15%
Active
• Vehicle
Vehicle gel

Locations

Country	Name	City	State
United States	Westlake Dermatology & Cosmetic Surgery	Austin	Texas
United States	Delricht Research	Baton Rouge	Louisiana
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Cahaba Dermatology Skin & Health Center	Birmingham	Alabama
United States	CoDerm Research	Centennial	Colorado
United States	Dermatology, Laser and Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	DeNova Research	Chicago	Illinois
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	J&S Studies, Inc.	College Station	Texas
United States	Driven Research, LLC	Coral Gables	Florida
United States	Florida Academic Dermatology Centers Research & Education, LLC	Coral Gables	Florida
United States	CCD Research, PLLC	Cromwell	Connecticut
United States	Modern Research Associates	Dallas	Texas
United States	Colorado Medical Research Center	Denver	Colorado
United States	Aventiv Research Inc.	Dublin	Ohio
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Hamzavi Dermatology, Inc.	Fort Gratiot	Michigan
United States	First OC Dermatology	Fountain Valley	California
United States	Advanced Research Associates	Glendale	Arizona
United States	Suzanne Bruce and Associates, P.A.	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	JDR Dermatology Research	Las Vegas	Nevada
United States	GSI Clinical Research	Margate	Florida
United States	Cordova Research Institute	Miami	Florida
United States	Yardley Dermatology Associates, PC	Morrisville	Pennsylvania
United States	DelRicht Research	New Orleans	Louisiana
United States	Etre, Cosmetic Dermatology and Laser Center	New Orleans	Louisiana
United States	Lupo Center for Aesthetic and General Dermatology	New Orleans	Louisiana
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	SkinSearch of Rochester	Rochester	New York
United States	DermAssociates	Rockville	Maryland
United States	Saint Louis University, Department of Dermatology	Saint Louis	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Advanced Medical Research PC	Sandy Springs	Georgia
United States	Valley Dermatology and Skin Cancer Center	Spokane	Washington
United States	MOORE Clinical Research, Inc.	Tampa	Florida
United States	The GW Medical Faculty Associates	Washington	District of Columbia
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Center for Clinical Studies, LTD.LLP	Webster	Texas
United States	Heartland Research Asssociates - AMR Company	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Botanix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.