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A Study Of BOTOX For The Treatment Of Glabellar Lines

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ClinicalTrials.gov Identifier: NCT00408785
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Glabellar Lines Drug: Botulinum Toxin Type A Drug: sodium chloride Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 256 participants
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
Actual Study Start Date : November 1, 2006
Actual Primary Completion Date : May 9, 2007
Actual Study Completion Date : May 9, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The investigator's rating of Glabellar line severity at maximum frown [ Time Frame: Day 30 after injection ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408785


Locations
China
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00408785     History of Changes
Other Study ID Numbers: 107457
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: November 2011

Keywords provided by GlaxoSmithKline:
Botulinum Toxin Type A
safety
efficacy
glabellar lines

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
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