A Study Of BOTOX For The Treatment Of Glabellar Lines

This study has been completed.

First Received: December 6, 2006 Last Updated: October 9, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00408785

Purpose

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.

Condition	Intervention	Phase
Glabellar Lines	Drug: Botulinum Toxin Type A	Phase III

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Double-Blind, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	256
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408785

Locations

China
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Beijing, China, 100853
GSK Investigational Site
Beijing, China, 100036

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107457
Study First Received:	December 6, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00408785 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Botulinum Toxin Type A
efficacy
glabellar lines
safety

Study placed in the following topic categories:

Botulinum Toxins
Botulinum Toxin Type A

Additional relevant MeSH terms:

Botulinum Toxins
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Neuromuscular Agents

Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 16, 2009