A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 7, 2016

Primary Completion Date

December 8, 2016

Study Completion Date

December 8, 2016

Conditions
Hyperhidrosis
Interventions
DRUG

Umeclidinium

Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colourless solution, free from visible particulates, for topical application. Each subject total daily dose will be calculated as per study reference manual (SRM) using subject's hand area. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm\^2. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects.

DRUG

Vehicle

The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application.This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm\^2

Trial Locations (6)

27612

GSK Investigational Site, Raleigh

68134

GSK Investigational Site, Omaha

77030

GSK Investigational Site, Houston

77845

GSK Investigational Site, College Station

78759

GSK Investigational Site, Austin

H2K 4L5

GSK Investigational Site, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Stiefel, a GSK Company

INDUSTRY