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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 29, 2015