drugset / Trial / NCT01791881
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm
RandomizedParallel-groupDouble-blindTreatment
Summary
To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA
Timeline
- Start
- 2008-04
- Primary completion
- 2009-05
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 1.25 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 2.5 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 12.5 iu | — |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 60 iu | — |
| Subject | Hugeltox | Protein / enzyme biologic | 1.25 iu | — |
| Subject | Hugeltox | Protein / enzyme biologic | 2.5 iu | — |
| Subject | Hugeltox | Protein / enzyme biologic | 12.5 iu | — |
| Subject | Hugeltox | Protein / enzyme biologic | 60 iu | — |