Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444626
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2007-03-07
Brief Title:
A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra DGE and an FDA Approved Device for the Correction of Nasolabial Folds NLFs
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Subject- and Evaluator-Blinded Randomized Multi-Center Study to Evaluate the Safety and Effectiveness of Injection With DGE Injectable Gel as Compared to an FDA-Approved Dermal Filler in Subjects Undergoing Cutaneous Correction of Nasolabial Folds
Status:
COMPLETED
Status Verified Date:
2015-04
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:
The purpose of this research study is to evaluate the safety and effectiveness of injection with DGE Injectable Gel hyaluronic acid with lidocaine manufactured by Genzyme Biosurgery as compared to injection with Restylane a Food and Drug Administration FDA approved dermal filler in patients undergoing cutaneous correction of the nasolabial folds NLFs
Detailed Description:
This study included an Initial and a Repeat Treatment period
The Initial Treatment period was a subject and evaluator-blinded randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold Both safety and efficacy were evaluated
In the Repeat Treatment Period participants received DGE in both NLFs Safety was evaluated
The Initial Treatment period was a subject and evaluator-blinded randomized split face study in which subjects received DGE in one nasolabial fold and Restylane in the other nasolabial fold Both safety and efficacy were evaluated
In the Repeat Treatment Period participants received DGE in both NLFs Safety was evaluated
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