DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up
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|ClinicalTrials.gov Identifier: NCT00444353|
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : April 23, 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 (Long Term Follow-up)|
|Study Start Date :||August 2004|
|Actual Study Completion Date :||January 2007|
- 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 assessments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444353
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Phyllis Diener, MT, ASCP||Sanofi|