"Sofpironium bromide"

Efficacy of sofpironium bromide gel on clozapine-induced hypersalivation in patients with treatment-resistant schizophrenia: double-blind, controlled crossover study. Hypersalivation is a major side-effect of clozapine in patients with treatment-resistant schizophrenia. We investigated the efficacy of topical anticholinergic formulation sofpironium bromide gel for improving hypersalivation in patients with treatment-resistant schizophrenia receiving clozapine. A double-blind, controlled crossover study was conducted with sofpironium bromide gel and a placebo gel to treat clozapine-induced hypersalivation in 16 patients with treatment-resistant schizophrenia. Patients were randomly divided between groups A and B (each = 8). Group A was treated with sofpironium bromide gel for 6 weeks

A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis. A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary

Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial. Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options. To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide. A phase II, multicenter in gravimetric sweat production. Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

Safety and Efficacy of Sofpironium Bromide for Primary Axillary Hyperhidrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials PROSPERO International prospective register of systematic reviews Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) 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. This is a multicenter, randomized, double-blind, vehicle-controlled

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) 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. This is a multicenter, randomized, double-blind, vehicle-controlled

and Meta-Analysis Protocol. PROSPERO 2023 CRD42023404592 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023404592Review questionP: Participants of any age and sex enrolled in a clinical trial allocated to a pharmaceutical intervention or placebo or vehicle for the treatment of hyperhidrosis.I: Glycopyrronium or glycopyrrolate, sofpironium bromide, oxybutynin, botulinum - 2/26/23, English only, no publication date restrictionTypes of study to be includedclinical trialsCondition or domain being studiedThe purpose of this review is to assess the efficiacy of different interventions for excessive sweating aka hyperhidrosisParticipants/populationthose with hyperhidrosisIntervention(s), exposure(s)botulinum toxin, aluminum chloride, sofpironium bromide, glycopyrrolate

A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis 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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis. This is an open-label, phase 2 long-term study designed to evaluate the safety, local tolerability, pharmacokinetics and efficacy of sofpironium bromide gel when applied

Official Title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 Concentrations of Topically Applied BBI-4000 (Sofpironium Bromide) Gel in Subjects With Axillary Hyperhidrosis Study Start Date : December 2016

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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.Condition or disease Intervention/treatment Phase Primary Axillary Hyperhidrosis Drug: Sofpironium Bromide Gel, 5% Drug: Sofpironium Bromide Gel, 15% Phase 3 Detailed Description: This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae.Subjects will apply the gel once daily at bedtime, to both

hyperhidrosis.Condition or disease Intervention/treatment Phase Hyperhidrosis Drug: BBI-4000, 15% Other: Vehicle gel Phase 2 Detailed Description: This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects with Palmar of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis Study Start Date : February 2016 Actual Primary Completion Date : June 2016