A Study Of BOTOX For The Treatment Of Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Lines
• Interventions: Drug: Botulinum Toxin Type A; Drug: sodium chloride

• Registration Number: NCT00408785
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-01
• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-06
• Study First Posted: 2006-12-07
• Primary Completion: 2007-05-09
• Study Completion: 2007-05-09
• Status Verified: 2011-11
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Botulinum Toxin Type A	Injection
B	sodium chloride	Injection

Primary Outcome Measures

Name	Time	Method
The investigator's rating of Glabellar line severity at maximum frown	Day 30 after injection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇳 Shanghai, China