DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
|ClinicalTrials.gov Identifier: NCT00444210|
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : April 10, 2008
This study is being undertaken to:
- evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment of dermal nasolabial fold wrinkles at 13 months following the last application of study treatment.
- Document the types and incidence of adverse events reported with DL6049 (injectable poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events will be assessed for an additional 12 months following discharge from the main study in subjects treated with DL6049.
|Condition or disease||Intervention/treatment||Phase|
|Nasolabial Fold Wrinkles||Device: DL6049 (injectable poly-L-lactic acid)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||June 2004|
|Study Completion Date :||April 2006|
- Primary: Evaluate degree of correction attainable with DL6049 compared to CosmoPlast Collagen Implant; in the treatment of dermal nasolabial fold wrinkles at 13 months following last application of study treatment.
- Treatment group comparisons at each timepoint of the treatment success rate (proportion of subjects with a photographic wrinkle severity grade of < 2), mean wrinkle severity grade, and investigator/subject global assessment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444210
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Phyllis Diener, MT, ASCP||Sanofi|