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)

Phase 3 Completed 140 enrolled Genzyme, a Sanofi Company Mentor Worldwide, LLC · collab

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2007-05
Primary completion: 2008-02
Completion: 2008-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Lidocaine	Other / unclassified	2.5 %	Topical
Background	prilocaine	Small molecule	2.5 %	Topical

Indications

No indication recorded.