Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02184988 | Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines | PHASE2 | COMPLETED | 352 | — | — | Aug 1, 2014 | Dec 1, 2015 | Apr 24, 2019 | 1 | United States |
The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
| Arm | Type | Description |
|---|---|---|
| Botulinum neurotoxin, Type A | EXPERIMENTAL | DWP-450 (Botulinum purified neurotoxin, Type A) Injection |
| Name | Type | Description |
|---|---|---|
| Botulinum purified neurotoxin, Type A | BIOLOGICAL | The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml. |
Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study): * Subjects must be an adult 18 years of age or over * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe...