Glabellar Lines
Conditions
Keywords
Botulinum Toxin Type A, safety, efficacy, glabellar lines
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.
Interventions
DRUGBotulinum Toxin Type A
botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg
DRUGsodium chloride
sodium chloride 0.9 mg
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The investigator's rating of Glabellar line severity at maximum frown | Day 30 after injection |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed