CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Sofpironium Bromide Gel, 15%drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03785587
NCT03785587Phase 2Completed
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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

Botanix Pharmaceuticals·interventional·Posted Dec 24, 2018·Updated Mar 14, 2023

In Brief

A Phase 2 clinical trial evaluating Sofpironium Bromide Gel, 15% for Primary Axillary Hyperhidrosis. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Axillary Hyperhidrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 24, 2018
Enrollment StartDec 21, 2018
Primary CompletionSep 6, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.5 years ago

Interventions

Sofpironium Bromide Gel, 15%drug

Sofpironium Bromide Gel, 15%