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A Study Of BOTOX For The Treatment Of Glabellar Lines

NCT ID: NCT00408785

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-01

Study Completion Date

2007-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Injection

Group Type EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type DRUG

botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg

B

Injection

Group Type PLACEBO_COMPARATOR

sodium chloride

Intervention Type DRUG

sodium chloride 0.9 mg

Interventions

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Botulinum Toxin Type A

botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg

Intervention Type DRUG

sodium chloride

sodium chloride 0.9 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.

Exclusion Criteria

* Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
* Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beijing, , China

Site Status

GSK Investigational Site

Beijing, , China

Site Status

GSK Investigational Site

Beijing, , China

Site Status

GSK Investigational Site

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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107457

Identifier Type: -

Identifier Source: org_study_id

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