A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines

GlaxoSmithKline1 site in 1 country256 target enrollmentNovember 1, 2006

ConditionsGlabellar Lines

InterventionsBotulinum Toxin Type A sodium chloride

DrugsBotulinum Toxin Type A sodium chloride

Overview

Phase: Phase 3
Intervention: Botulinum Toxin Type A
Conditions: Glabellar Lines
Sponsor: GlaxoSmithKline
Enrollment: 256
Locations: 1
Primary Endpoint: The investigator's rating of Glabellar line severity at maximum frown
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.

Registry

clinicaltrials.gov

Start Date

November 1, 2006

End Date

May 9, 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

A

Injection

Intervention: Botulinum Toxin Type A

B

Injection

Intervention: sodium chloride

Outcomes

Primary Outcomes

The investigator's rating of Glabellar line severity at maximum frown

Time Frame: Day 30 after injection

Secondary Outcomes

Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.(Day 7, 30, 60, 90, 120 after injection)