Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
- Conditions
- Axillary Hyperhidrosis
- Interventions
- Drug: Sofpironium Bromide Gel, 15%Drug: Vehicle
- Registration Number
- NCT03836287
- Lead Sponsor
- Botanix Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Sofpironium Bromide Gel, 15% Sofpironium bromide, 15% gel, once per day Vehicle Vehicle Vehicle gel, once per day
- Primary Outcome Measures
Name Time Method Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment 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. 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.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 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. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Lawrence J Green, MD LLC
🇺🇸Rockville, Maryland, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Dawes Fretzin Research Group
🇺🇸Indianapolis, Indiana, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Skin Care Research, LLC
🇺🇸Boca Raton, Florida, United States
Total Skin and Beauty Dermatology Center, P.C.
🇺🇸Birmingham, Alabama, United States
Oregon Dermatology & Research Center
🇺🇸Portland, Oregon, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Skin Specialists, P.C.
🇺🇸Omaha, Nebraska, United States
Investigate MD, LLC
🇺🇸Scottsdale, Arizona, United States
Northwest Arkansas Clinical Trials Center
🇺🇸Rogers, Arkansas, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Center for Clinical & Cosmetic Research
🇺🇸Aventura, Florida, United States
Skin Research Institute
🇺🇸Coral Gables, Florida, United States
Aby's New Generation Research
🇺🇸Hialeah, Florida, United States
Tory Sullivan, MD PA
🇺🇸North Miami Beach, Florida, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
Baumann Cosmetic and Research Institute
🇺🇸Miami, Florida, United States
My Community Research Center, Inc.
🇺🇸Miami, Florida, United States
Research Institute of the Southeast
🇺🇸West Palm Beach, Florida, United States
Maryland Laser Skin and Vein
🇺🇸Hunt Valley, Maryland, United States
SkinCare Physicians
🇺🇸Chestnut Hill, Massachusetts, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Minnesota Clinical Study Center
🇺🇸New Brighton, Minnesota, United States
PMG Research of Cary
🇺🇸Raleigh, North Carolina, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
DermResearch Center of New York, Inc.
🇺🇸Stony Brook, New York, United States
Haber Dermatology and Cosmetic Surgery, Inc.
🇺🇸Beachwood, Ohio, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Dermatology Associates of Seattle
🇺🇸Seattle, Washington, United States
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
AboutSkin Research, LLC
🇺🇸Greenwood Village, Colorado, United States