Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-08 @ 1:46 AM
Study NCT ID:
NCT01308060
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2011-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
A Multi-center Randomized, Double-blind, Placebo Controlled, Parallel-group Study of CD07743 for the Improvement of Lateral Canthal Lines (Crow's Feet)
Status:
COMPLETED
Status Verified Date:
2012-08
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 double-blind study has two parts for each subject (same population):
Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):
* To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.
Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):
* To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
* To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs.
Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):
* To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.
Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):
* To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
* To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: