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:
Genzyme, a Sanofi Company
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00417469
First received: December 28, 2006
Last updated: July 31, 2009
Last verified: February 2007
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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 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 Genzyme, a Sanofi Company:
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 |
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
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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
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: | July 31, 2009 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on March 03, 2015