NCT00417469

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)

A Single-Blind, Randomized, Single-Center Evaluation of Procedural and Post Procedural Pain Experienced With Injections of NADG With Lidocaine Injectable Gel as Compared to Captique® Injectable Gel in Subjects Undergoing Cutaneous Correction of Nasolabial Folds

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (planned)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

45 subjects are planned; a portion of these subjects will have skin of color

Conditions

• Facial Wrinkles

Interventions

Type	Name	Description
DEVICE	NADGL

Timeline

• Start date: 2007-01-01
• Completion: 2007-02-01
• First posted: 2007-01-01
• Last updated: 2015-03-05

Locations

1 site across 1 country: United States