drugset / Trial / NCT04996810
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
Timeline
- Start
- 2020-12-10
- Primary completion
- 2021-04-02
- Completion
- 2021-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 20 unknown | — |
| Subject | PROTOXIN | Protein / enzyme biologic | 20 unknown | — |
Indications
No indication recorded.