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)

Completed · Phase 3

Conditions studied: Facial Wrinkles at the Nasolabial Folds

In brief

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).

Key facts

Study ID

NCT00444626

Run by

Genzyme, a Sanofi Company

People needed

140

Starts

2007-05-01

Expected to finish

2008-07-01

Last updated by the study team

2015-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — La Jolla, California, United States
• Study site — Miami Beach, Florida, United States
• Study site — Westwood, New Jersey, United States
• Study site — White Plains, New York, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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