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)

Completed · Phase 3

Conditions studied: Facial Wrinkles

In brief

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.

Key facts

Study ID

NCT00417469

Run by

Genzyme, a Sanofi Company

People needed

45

Starts

2007-01-01

Expected to finish

2007-02-01

Last updated by the study team

2015-03-05

Who can join

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

You may qualify if…

• bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale.

You may not qualify if…

• pregnant/lactating women
• subjects who have an allergy to lidocaine or other amide-type anesthetics

Where it is running

• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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