A Study Of BOTOX For The Treatment Of Glabellar Lines - Full Text View

Sponsor:	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 Drug: sodium chloride	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Chlorides Botulinum toxin A Clostridium botulinum toxin Sodium chloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The investigator's rating of Glabellar line severity at maximum frown [ Time Frame: Day 30 after injection ] [ Designated as safety issue: No ]

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. [ Time Frame: Day 7, 30, 60, 90, 120 after injection ] [ Designated as safety issue: No ]

Estimated Enrollment:	256
Study Start Date:	November 2006

Arms	Assigned Interventions
Experimental: A Injection	Drug: Botulinum Toxin Type A botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
Placebo Comparator: B Injection	Drug: sodium chloride sodium chloride 0.9 mg

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00408785 History of Changes
Other Study ID Numbers:	107457
Study First Received:	December 6, 2006
Last Updated:	November 10, 2011
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Botulinum Toxin Type A
safety
efficacy
glabellar lines

Additional relevant MeSH terms:

Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012