Conditions: Hyperhidrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 189
Healthy volunteers: no

Brief 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.

Detailed description:
This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with Axillary Hyperhidrosis.

Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4 week treatment period will be followed by a 2 week follow-up period.

Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology and serum chemistry laboratory testing and ECGs.

Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported outcome) and through gravimetrically measured sweat production.

PK blood samples will be taken from study subjects from selected centers.

Arms:
arm 1: Low concentration of BBI-4000; BBI-4000 Gel, 5% arm 2: Middle concentration of BBI-4000; BBI-4000 Gel, 10% arm 3: High concentration of BBI-4000; BBI-4000 Gel, 15% arm 4: Vehicle (placebo); BBI-4000 Gel, 0%

Interventions: intervention 1: BBI-4000 Gel, 5% intervention 2: BBI-4000 Gel, 10% intervention 3: BBI-4000 Gel, 15% intervention 4: Vehicle
Intervention descriptions: intervention 1: BBI-4000 Gel, 5% intervention 2: BBI-4000 Gel, 10% intervention 3: BBI-4000 Gel, 15% intervention 4: Placebo, BBI-4000 Gel, 0%

Protocol document: