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)

• Status: Completed
• Trial end date: 2008-07-01

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).

• Phase: Phase 3

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Collaborator: Mentor Worldwide, LLC
• Treatments: EMLA; Hyaluronic Acid; Lidocaine; Lidocaine, Prilocaine Drug Combination; Prilocaine