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

NCT03627468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-05-19

Study results available
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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.

Conditions

  • Primary Axillary Hyperhidrosis

Interventions

DRUG

Sofpironium Bromide Gel, 5%

Sofpironium Bromide Gel, 5%

DRUG

Sofpironium Bromide Gel, 15%

Sofpironium Bromide Gel, 15%

Sponsors & Collaborators

  • Botanix Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Patricia Walker, MD PhD · Botanix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03627468 on ClinicalTrials.gov