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

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
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: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Botulinum Toxin Type A
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 April 16, 2014