A Study Of BOTOX For The Treatment Of Glabellar Lines
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines
1 other identifier
interventional
256
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 6, 2006
CompletedFirst Posted
Study publicly available on registry
December 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2007
CompletedMay 31, 2017
November 1, 2011
6 months
December 6, 2006
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The investigator's rating of Glabellar line severity at maximum frown
Day 30 after injection
Secondary Outcomes (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.
Day 7, 30, 60, 90, 120 after injection
Study Arms (2)
A
EXPERIMENTALInjection
B
PLACEBO COMPARATORInjection
Interventions
botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
Eligibility Criteria
You may qualify if:
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Beijing, 100034, China
GSK Investigational Site
Beijing, 100036, China
GSK Investigational Site
Beijing, 100853, China
GSK Investigational Site
Shanghai, 200040, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2006
First Posted
December 7, 2006
Study Start
November 1, 2006
Primary Completion
May 9, 2007
Study Completion
May 9, 2007
Last Updated
May 31, 2017
Record last verified: 2011-11