Ignite Creation Date:
2025-12-18 @ 8:16 AM
Ignite Modification Date:
2025-12-18 @ 8:16 AM
Study NCT ID:
NCT02334423
Status:
None
Last Update Posted:
2019-03-27 00:00:00
First Post:
2015-01-06 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
Sponsor:
None
Organization:
Study Overview
Official Title:
A Phase III, Multi-center, Randomized, Double Blind, Placebo-controlled, Single Dose, Trial to Demonstrate the Safety and Efficacy of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines
Status:
None
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Three hundred and twenty-four eligible subjects will be randomly assigned 3:1 to receive DWP-450 or placebo. Safety and efficacy will be assessed on Days 2, 7, 14, 30, 90, 120 and 150. The primary efficacy end point assesses the effectiveness of the DWP-450 against placebo on Day 30 in a superiority design.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: