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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02334423 | A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001 | PHASE3 | COMPLETED | 330 | — | — | Jan 1, 2015 | Dec 1, 2015 | Mar 27, 2019 | 1 | United States |
| NCT02334436 | A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002 | PHASE3 | COMPLETED | 324 | — | — | Jan 1, 2015 | Dec 1, 2015 | Mar 27, 2019 | 1 | United States |
The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.
| Arm | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | EXPERIMENTAL | Botulinum toxin, Type A |
| Placebo | PLACEBO_COMPARATOR | 0.9 % sterile, unpreserved saline |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin, Type A | BIOLOGICAL | Botulinum toxin, Type A |
| 0.9% sterile, unpreserved saline | OTHER | Placebo |
Inclusion Criteria: * Subjects is an adult, of at least 18 years of age * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS * Subject has moderate to severe g...