Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)

Axillary Hyperhidrosis Clinical Trial

— CardiganI  

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: NCT03836287
• Other study ID #: BBI-4000-CL-301
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2020
• Est. completion date: June 25, 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: 350
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 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 Gel, 15%
Active
• Vehicle
Vehicle gel

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	Center for Clinical & Cosmetic Research	Aventura	Florida
United States	Haber Dermatology and Cosmetic Surgery, Inc.	Beachwood	Ohio
United States	Hassman Research Institute	Berlin	New Jersey
United States	Total Skin and Beauty Dermatology Center, P.C.	Birmingham	Alabama
United States	Skin Care Research, LLC	Boca Raton	Florida
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	SkinCare Physicians	Chestnut Hill	Massachusetts
United States	Skin Research Institute	Coral Gables	Florida
United States	California Dermatology & Clinical Research Institute	Encinitas	California
United States	Finlay Medical Research	Greenacres City	Florida
United States	AboutSkin Research, LLC	Greenwood Village	Colorado
United States	Aby's New Generation Research	Hialeah	Florida
United States	Maryland Laser Skin and Vein	Hunt Valley	Maryland
United States	Dawes Fretzin Research Group	Indianapolis	Indiana
United States	Dermatology Research Associates	Los Angeles	California
United States	Baumann Cosmetic and Research Institute	Miami	Florida
United States	International Dermatology Research, Inc.	Miami	Florida
United States	My Community Research Center, Inc.	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Tory Sullivan, MD PA	North Miami Beach	Florida
United States	Skin Specialists, P.C.	Omaha	Nebraska
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	PMG Research of Cary	Raleigh	North Carolina
United States	Lawrence J Green, MD LLC	Rockville	Maryland
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Progressive Clinical Research	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Investigate MD, LLC	Scottsdale	Arizona
United States	Dermatology Associates of Seattle	Seattle	Washington
United States	DermResearch Center of New York, Inc.	Stony Brook	New York
United States	Grekin Skin Institute	Warren	Michigan
United States	Research Institute of the Southeast	West Palm Beach	Florida

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.