DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up
This study has been completed.
Information provided by:
First received: March 5, 2007
Last updated: April 22, 2008
Last verified: April 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.
Nasolabial Fold Wrinkles
Device: DL6049 (injectable poly-L-lactic acid)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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)|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||August 2004|
|Study Completion Date:||January 2007|
Contacts and Locations