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J Eur Acad Dermatol Venereol. 2018 Jan;32(1):145-151. doi: 10.1111/jdv.14651. Epub 2017 Nov 7.

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.

Author information

1
Wake Research Institute, Raleigh, NC, USA.
2
Innovaderm Research Inc., Montreal, QC, Canada.
3
DermResearch Inc., Austin, TX, USA.
4
Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Upper Merion, PA, USA.
5
Dermatology Therapeutic Area Unit, GlaxoSmithKline, Collegeville, PA, USA.

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 the treatment. Nine subjects (50%) on UMEC and two subjects (40%) on vehicle reported AEs, most commonly application site reactions. At Day 15, seven subjects (41%) in UMEC and two subjects (40%) in vehicle had at least a 50% reduction in sweat production. Eight subjects (47%) in UMEC and one subject (20%) in vehicle had at least a two-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.

PMID:
29055158
DOI:
10.1111/jdv.14651
[Indexed for MEDLINE]

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