A Study Of BOTOX For The Treatment Of Glabellar Lines

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 6, 2006
Last updated: November 10, 2011
Last verified: November 2011
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 3

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:

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
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
Drug: sodium chloride
sodium chloride 0.9 mg


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

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

GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Beijing, China, 100036
GSK Investigational Site
Beijing, China, 100853
GSK Investigational Site
Shanghai, China, 200040
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Botulinum Toxin Type A
glabellar lines

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neuromuscular Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016