At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 227 enrolled
Drug / intervention
BBI-4000 gel, 5% +3 moredrug
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.
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
In Brief
A Phase 2 clinical trial evaluating BBI-4000 gel, 5%, BBI-4000 gel, 10%, and 2 other interventions for Hyperhidrosis. Completed, enrolled 227 participants.
Detailed Summary
This study is being conducted to assess the safety and efficacy of 3 concentrations of BBI-4000 and vehicle (4 treatment arms), applied for the treatment of axillary hyperhidrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperhidrosis
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedJan 2017
Primary CompletionSep 2017
TodayJul 2026
First PostedJan 18, 2017
Enrollment StartDec 22, 2016
Primary CompletionSep 19, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.5 years ago
Interventions
BBI-4000 gel, 5%drug
BBI-4000 gel, 5% applied once to each axilla daily
BBI-4000 gel, 10%drug
BBI-4000 gel, 10% applied once to each axilla daily
BBI-4000 gel, 15%drug
BBI-4000 gel, 15% applied once to each axilla daily
Vehicle (Placebo)drug
Placebo, applied once to each axilla daily