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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(s) -
Nasir A.,
Bissonnette R.,
Maari C.,
DuBois J.,
Pene Dumitrescu T.,
Haddad J.,
Yamaguchi Y.,
Dalessandro M.
Publication year - 2018
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.14651
Subject(s) - medicine , tolerability , clinical endpoint , randomized controlled trial , hyperhidrosis , clinical trial , adverse effect , crossover study , anesthesia , randomization , placebo , alternative medicine , pathology
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.