A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs) - Full Text View

Sponsors and Collaborators:	Genzyme Mentor Corporation
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00444626

Purpose

The purpose of this research study is to evaluate the effects (good and bad) of DGE Injectable Gel (manufactured by Genzyme Biosurgery) with a Food and Drug Administration (FDA) approved dermal filler in the nasolabial folds and to see how they perform compared to each other. DGE is an investigational product that is not FDA approved.

Condition	Intervention	Phase
Facial Wrinkles at the Nasolabial Folds	Device: Dermal Gel Extra (DGE) Device: RESTYLANE	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Subject- and Evaluator-Blinded, Randomized, Multi-Center Study to Evaluate the Safety and Effectiveness of Injection With DGE Injectable Gel as Compared to an FDA-Approved Dermal Filler in Subjects Undergoing Cutaneous Correction of Nasolabial Folds

Further study details as provided by Genzyme:

Primary Outcome Measures:

The comparison between DGE and the FDA approved dermal filler mean change in wrinkle improvement at Baseline and the Week 24 score for each NLF [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject pain assessment during and after injection procedure [ Time Frame: 0 ] [ Designated as safety issue: No ]
The comparison between DGE and the FDA approved dermal filler mean change in wrinkle improvement at Baseline and the Week 36 score for each NLF [ Time Frame: week 36 ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	May 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Correction of the facial wrinkles (NLFs)	Device: Dermal Gel Extra (DGE) Correction of the facial wrinkles (NLFs)
2: Active Comparator Correction of the facial wrinkles (NLFs)	Device: RESTYLANE Correction of the facial wrinkles (NLFs)

Detailed Description:

A portion of subjects having skin of color.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, prilocaine or other amide-type anesthetic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444626

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205
United States, California

La Jolla, California, United States, 92037
United States, Florida

Miami Beach, Florida, United States, 33140
United States, New Jersey

Westwood, New Jersey, United States, 07675
United States, New York

White Plains, New York, United States, 10640
United States, Tennessee

Nashville, Tennessee, United States, 37215

Sponsors and Collaborators

Genzyme

Mentor Corporation

Investigators

Study Director:

Brian Kinney, MD (Medical Monitor)

Mentor Corporation

More Information

Study ID Numbers:	DGE00105
Study First Received:	March 7, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00444626
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on January 16, 2009