drugset / Trial / NCT00770211
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
RandomizedParallel-groupDouble-blindTreatment
Summary
The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.
Timeline
- Start
- 2008-10
- Primary completion
- 2009-03
- Completion
- 2009-06
Outcome
Met primary endpoint
registry IncobotulinumtoxinA (Xeomin) (20 Units) vs Placebo; p <0.0001; Difference response rate 0.48 (95% CI 0.40 to 0.56); Fisher Exact NCT00770211 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 20 iu | Intramuscular |
Indications
No indication recorded.