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.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00417469

First received: December 28, 2006

Last updated: March 4, 2015

Last verified: March 2015

History of Changes

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:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
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 Sanofi:

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
Study Completion Date:	February 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 (Adult, Senior)
Sexes Eligible for Study:	All

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Alabama

Birmingham, Alabama, United States, 35205

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators


Study Director:	Medical Monitor	Genzyme, a Sanofi Company

More Information


Responsible Party:	Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier:	NCT00417469 History of Changes
Other Study ID Numbers:	NADGL00106
Study First Received:	December 28, 2006
Last Updated:	March 4, 2015

ClinicalTrials.gov processed this record on July 27, 2017

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