At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
BBI-4000, 15% +1 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 Local Tolerability of Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel in Subjects With Palmar Hyperhidrosis
In Brief
A Phase 2 clinical trial evaluating BBI-4000, 15% and Vehicle gel for Hyperhidrosis. Completed, enrolled 50 participants across 5 sites.
Detailed Summary
To assess the safety and local tolerability of BBI-4000 15% gel compared with vehicle (placebo) when applied topically once daily in subjects with palmar hyperhidrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperhidrosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionJul 2016
Study CompletionOct 2016
TodayJul 2026
First PostedFeb 15, 2016
Enrollment StartMar 8, 2016
Primary CompletionJul 14, 2016
Study CompletionOct 4, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.4 years ago
Interventions
BBI-4000, 15%drug
Vehicle gelother