Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-03-05 @ 8:33 PM
Study NCT ID:
NCT03627468
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2018-08-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
Sponsor:
Botanix Pharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study of Topically Applied Sofpironium Bromide (BBI-4000) Gel, 5% and 15% in Subjects With Axillary Hyperhidrosis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
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 axillae.
A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.
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 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 17 scheduled visits to take place over a 52 week period.
Subjects will apply the gel once daily at bedtime, to both axillae.
A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.
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 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 17 scheduled visits to take place over a 52 week period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: