At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 189 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 Blind, Vehicle-Controlled Study to Evaluate the Safety and Effect on Sweat Production of 3 Concentrations of Topically Applied BBI-4000 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 189 participants across 12 sites.
Detailed Summary
To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperhidrosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMar 2015
Primary CompletionNov 2015
TodayJul 2026
First PostedJan 13, 2015
Enrollment StartMar 10, 2015
Primary CompletionNov 5, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.5 years ago
Interventions
BBI-4000 Gel, 5%drug
BBI-4000 Gel, 5%
BBI-4000 Gel, 10%drug
BBI-4000 Gel, 10%
BBI-4000 Gel, 15%drug
BBI-4000 Gel, 15%
Vehicledrug
Placebo, BBI-4000 Gel, 0%