Trials / Completed
CompletedNCT01237977
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Medy-Tox · Industry
- Sex
- All
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
Detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Botulinum Toxin Type A(Meditoxin®) | single administration, Day 0, 20U |
| DRUG | Botulinum Toxin Type A(Botox®) | single administration, Day 0, 20U |
Timeline
- Start date
- 2009-11-23
- Primary completion
- 2010-08-30
- Completion
- 2010-09-30
- First posted
- 2010-11-10
- Last updated
- 2019-03-28
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01237977. Inclusion in this directory is not an endorsement.