drugset / Trial / NCT01032954
Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-12
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin | Protein / enzyme biologic | 125 iu | Other |
| Comparator | Botulinum toxin | Protein / enzyme biologic | 170 iu | Other |
| Comparator | Botulinum toxin | Protein / enzyme biologic | 171 iu | Other |
| Comparator | Botulinum toxin | Protein / enzyme biologic | 210 iu | Other |
| Comparator | Botulinum toxin | Protein / enzyme biologic | 211 iu | Other |
| Comparator | Botulinum toxin | Protein / enzyme biologic | 250 iu | Other |
Indications
No indication recorded.