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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00444210 |
This study is being undertaken to:
Condition | Intervention | Phase |
---|---|---|
Nasolabial Fold Wrinkles |
Device: DL6049 (injectable poly-L-lactic acid) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study of the Safety and Effectiveness of DL6049 (Injectable Poly-L-Lactic Acid) Versus CosmoPlast Collagen Implant in the Treatment of Nasolabial Fold Wrinkles |
Estimated Enrollment: | 240 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | DL6049-0301 |
Study First Received: | March 5, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00444210 History of Changes |
Health Authority: | United States: Food and Drug Administration |