Glabellar Lines Clinical Trial
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
| Verified date | November 2011 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 256 |
| Est. completion date | May 9, 2007 |
| Est. primary completion date | May 9, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | GSK Investigational Site | Beijing | |
| China | GSK Investigational Site | Beijing | |
| China | GSK Investigational Site | Beijing | |
| China | GSK Investigational Site | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The investigator's rating of Glabellar line severity at maximum frown | Day 30 after injection | ||
| Secondary | 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 |
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