Conditions: Hyperhidrosis
Keywords: Topical Palmar Hyperhidrosis Umeclidinium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
Umeclidinium (UMEC) is a potent pan-active long-acting muscarinic antagonist (LAMA). It is anticipated that topical administration of UMEC will block stimulation of muscarinic receptors, thereby reducing the overproduction of sweat in subjects who suffer from hyperhidrosis. This study will assess the clinical effect, pharmacokinetics, safety and tolerability of topically applied UMEC following once daily topical administration, for 28 days, to the palms, in subjects with primary palmar hyperhidrosis. The study will also investigate if topically applied UMEC, at the highest possible concentration, will decrease palmar hyperhidrosis with a systemic anticholinergic adverse event profile similar to or below that observed with inhaled administration. This is a double blind (Sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study. Study will enrol up to 55 subjects.

Detailed description:

Arms:
arm 1: Subjects will apply UMEC topically once daily (2microliter \[µL\]/centimeter \[cm\]\^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Randomization will be 4:1 (UMEC 1.85%: vehicle) arm 2: subjects will apply vehicle topical once daily (2µL/cm\^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.

Interventions: intervention 1: Umeclidinium intervention 2: Vehicle
Intervention descriptions: intervention 1: 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. intervention 2: 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

Protocol document: