Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis
Status:
Completed
Trial end date:
2016-02-25
Target enrollment:
Participant gender:
Summary
This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo
controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical
effect of topically applied umeclidinium following once daily topical administration to
axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine
whether topically applied umeclidinium can decrease hyperhidrosis without systemic
anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at
the highest possible concentration.
Subjects will be dosed by site staff each night immediately before bedtime for 14 days.
Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS)
measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic
sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of
the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24
subjects.