Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417469
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2006-12-28
Brief Title:
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds NLFs
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Single-Blind Randomized Single-Center Evaluation of Procedural and Post Procedural Pain Experienced With Injections of NADG With Lidocaine Injectable Gel as Compared to Captique Injectable Gel in Subjects Undergoing Cutaneous Correction of Nasolabial Folds
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique Injectable Gel in the nasolabial folds Captique is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery Ridgefield NJ NADGL is a new product not FDA approved with lidocaine and is also manufactured by Genzyme Biosurgery We do not know which of these treatments results in less pain during and after injection The safety of NADGL is also being studied
Detailed Description:
45 subjects are planned a portion of these subjects will have skin of color
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?:
None