NCT03785587

A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis

A Multi-Center Open-Label Extension Study to Assess the Long-Term Safety Tolerability and Pharmacokinetics of Sofpironium Bromide Gel 15% Applied Topically to Children and Adolescents Age 9-17 Years Previously Enrolled in BBI-4000-CL-105

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Botanix Pharmaceuticals · Industry
• Sex: All
• Age: 9 Years – 16 Years
• Healthy volunteers: Not accepted

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. 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.

Detailed description

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 topically to the axillae. Subjects will apply the gel once daily at bedtime, to both axillae. A maximum of 24 subjects, will be enrolled to receive sofpironium bromide gel, 15%. Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 pharmacokinetics, 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 8 scheduled visits to take place over a 26 week period.

Conditions

• Primary Axillary Hyperhidrosis

Interventions

Type	Name	Description
DRUG	Sofpironium Bromide Gel, 15%	Sofpironium Bromide Gel, 15%

Timeline

• Start date: 2018-12-21
• Primary completion: 2019-09-06
• Completion: 2019-09-06
• First posted: 2018-12-24
• Last updated: 2023-03-14
• Results posted: 2023-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study