Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411002
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-08
Brief Title:
Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines
Sponsor:
Revance Therapeutics Inc
Organization:
Revance Therapeutics Inc
Study Overview
Official Title:
A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This is a Phase 2a open-label single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm DAXI for Injection on the treatment of dynamic forehead lines FHL and glabellar lines GL
Approximately 40 subjects 18 years of age and above with moderate to severe GL and FHL all assessed at maximum contraction will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection
Approximately 40 subjects 18 years of age and above with moderate to severe GL and FHL all assessed at maximum contraction will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None