NADGL00106: 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)

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00417469

Purpose

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.

Condition	Intervention	Phase
Facial Wrinkles	Device: NADGL	Phase 3

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: 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

Further Study Details:

Primary Outcomes: To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs).
Secondary Outcomes: To evaluate the safety of NADGL.

Expected Total Enrollment: 45
(45 subjects are planned; a portion of these subjects will have skin of color)

Study Start: 2007-01

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Location and Contact Information

Alabama
Birmingham, Alabama, 35205, United States

More Information

Study ID Numbers: NADGL00106
ClinicalTrials.gov Identifier: NCT00417469
Health Authority: United States: Food and Drug Administration