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

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


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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Axilla
  • Double-Blind Method
  • Female
  • Humans
  • Hyperhidrosis / drug therapy*
  • Male
  • Middle Aged
  • Muscarinic Antagonists / adverse effects*
  • Muscarinic Antagonists / blood
  • Muscarinic Antagonists / pharmacokinetics
  • Muscarinic Antagonists / therapeutic use
  • Proof of Concept Study
  • Quinuclidines / adverse effects*
  • Quinuclidines / blood
  • Quinuclidines / pharmacokinetics
  • Quinuclidines / therapeutic use
  • Severity of Illness Index
  • Sweating / drug effects*
  • Young Adult


  • GSK573719
  • Muscarinic Antagonists
  • Quinuclidines