A Study Of BOTOX For The Treatment Of Glabellar Lines
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glabellar Lines
Intervention: Botulinum Toxin Type A (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The investigator's rating of Glabellar line severity at maximum frown
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Beijing 100853, China
GSK Clinical Trials Call Center, Beijing 100036, China
GSK Clinical Trials Call Center, Shanghai 200040, China
GSK Clinical Trials Call Center, Beijing 100034, China
Additional Information
Starting date: November 2006
Last updated: February 18, 2008
|
