Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (Cardigan II)
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|ClinicalTrials.gov Identifier: NCT03948646|
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : August 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Axillary Hyperhidrosis||Drug: Sofpironium Bromide, 15% Drug: Vehicle||Phase 3|
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 450 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Sofpironium bromide, 15% gel, once per day
Drug: Sofpironium Bromide, 15%
Placebo Comparator: Vehicle
Vehicle gel, once per day
- The number of participants with treatment emergent adverse events [ Time Frame: Through study completion (6 weeks). ]Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe
- Change in Hyperhidrosis Disease Severity Measure-Axillary score [ Time Frame: 6 weeks ]Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).
- Gravimetric sweat production [ Time Frame: 6 weeks ]Change in the measured weight of axillary sweat production from baseline to end of study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948646
|Contact: Brandon M Kirsch, MDemail@example.com|
|Contact: Larry A Romel, MSfirstname.lastname@example.org|