MIAMI BEACH – A promising new treatment for axillary hyperhidrosis will soon be evaluated in a clinical trial.
The novel molecular compound – a “soft anticholinergic” – was safe and effective as a topical treatment in a recent pilot study, Dr. Brian Berman reported in a session on innovations in clinical therapeutics at the South Beach Symposium.
Currently known as BBI-4000, the product is locally active but quickly metabolized if absorbed, which reduces the risk of treatment-related adverse events, said Dr. Berman of the University of Miami.
Dr. Brian Berman
No comparable first-line topical prescription treatment exists for axillary hyperhidrosis, he noted.
In the pilot study – the results of which were reported in September by the manufacturer, Brickell Biotech – 18 subjects were randomized to receive once-daily treatment with either a high topical concentration, a low topical concentration, or topical vehicle for 14 days. Of the 12 patients receiving active treatment, 75% achieved at least a 50% sweat reduction, compared with 33% of the 6 patients in the vehicle group.
Further, 67% of those receiving active treatment, compared with 33% in the vehicle group, achieved at least a two-point improvement in their Hyperhidrosis Disease Severity Scale score, indicating substantial improvement, Dr. Berman said.
No treatment-related adverse events were reported, and none of the patients discontinued treatment because of adverse events.
Based on these findings, Brickell Biotech has initiated a randomized, double-blind, vehicle-controlled phase IIb clinical trial with plans to enroll 180 patients with primary axillary hyperhidrosis. The trial will assess the safety and efficacy of three different concentrations of BBI-4000, compared with vehicle.
Dr. Berman is a consultant, researcher, and/or speaker for Beiersdorf, DUSA Pharmaceuticals, Ferndale Pharmaceuticals, Galderma Laboratories, Genentech, Halscion, LEO Pharmaceuticals, Onset Therapeutics, Sensus Healthcare, Tigercat Pharma, and TopMD Skin Care. He also owns stock in TopMD Skin Care.