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

Hyperhidrosis Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Including an Open-label Phase to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Axillary Hyperhidrosis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01128738
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date April 2010
Completion date August 2011
View Details
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