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A Study Of BOTOX For The Treatment Of Glabellar Lines

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 6, 2006
Last updated: May 30, 2017
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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 ]

Estimated Enrollment: 256
Actual Study Start Date: November 1, 2006
Study Completion Date: May 9, 2007
Primary Completion Date: May 9, 2007 (Final data collection date for primary outcome measure)
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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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: GlaxoSmithKline Identifier: NCT00408785     History of Changes
Other Study ID Numbers: 107457
Study First Received: December 6, 2006
Last Updated: May 30, 2017

Keywords provided by GlaxoSmithKline:
Botulinum Toxin Type A
glabellar lines

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on September 21, 2017