Status:
COMPLETED
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)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Facial Wrinkles
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 witho...
Detailed Description
45 subjects are planned; a portion of these subjects will have skin of color
Eligibility Criteria
Inclusion
- bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale.
Exclusion
- pregnant/lactating women
- subjects who have an allergy to lidocaine or other amide-type anesthetics
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00417469
Start Date
January 1 2007
End Date
February 1 2007
Last Update
March 5 2015
Active Locations (1)
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1
Birmingham, Alabama, United States, 35205