A Phase 2a Randomized Controlled Study to Evaluate the Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topically Applied Umeclidinium in Subjects with Primary Axillary Hyperhidrosis

Abstract

Background

Hyperhidrosis is a common medical condition which can have a significant impact on quality of life. Umeclidinium (UMEC) is a long acting muscarinic antagonist (LAMA) developed as a dermal formulation.

Objectives

This 2-week, double-blind, randomized, vehicle-controlled study evaluated systemic exposure, safety, and tolerability of topically administered UMEC in subjects with primary axillary hyperhidrosis. Clinical effect was a secondary objective, measured by gravimetry and the hyperhidrosis disease severity scale (HDSS). Vehicle was included to evaluate safety.

Methods

Twenty-three subjects were randomized to either 1.85% UMEC (N=18) or vehicle (N=5) once daily.

Results

Measurable plasma concentrations were observed in 78% of subjects after treatment. Nine subjects (50%) on UMEC and 2 subjects (40%) on vehicle reported AEs, most commonly application site reactions. At Day 15, 7 subjects (41%) in UMEC and 2 subjects (40%) in vehicle had at least a 50% reduction in sweat production. Eight subjects (47%) in UMEC and 1 subject (20%) in vehicle had at least a 2-point reduction in HDSS. No comparisons of treatment arms were planned prospectively.

Conclusions

The measurable exposure, acceptable safety, and preliminary clinical activity observed in this proof-of-concept study suggest the potential clinical utility of topical UMEC in subjects with axillary hyperhidrosis.

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