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.

First Received: December 28, 2006 Last Updated: July 31, 2009 History of Changes

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 III

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 as provided by Genzyme:

Primary Outcome Measures:

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 Outcome Measures:

To evaluate the safety of NADGL.

Estimated Enrollment:	45
Study Start Date:	January 2007

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417469

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	NADGL00106
Study First Received:	December 28, 2006
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00417469 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Facies
Lidocaine
Pain

ClinicalTrials.gov processed this record on September 11, 2009