drugset / Trial / NCT01128738

GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

NCT01128738 ↗

Phase 3 Completed 152 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.

Timeline

Start
2010-04
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator GSK1358820 Protein / enzyme biologic 100 iu Other