Trials / Completed
CompletedNCT00444210
DL6049 vs CosmoPlast in the Treatment of Nasolabial Fold Wrinkles
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (planned)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DL6049 (injectable poly-L-lactic acid) |
Timeline
- Start date
- 2004-06-01
- Completion
- 2006-04-01
- First posted
- 2007-03-07
- Last updated
- 2019-09-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00444210. Inclusion in this directory is not an endorsement.