NCT00444353

DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up

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)

• 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

• Nasolabial Fold Wrinkles

Interventions

Type	Name	Description
DEVICE	DL6049 (injectable poly-L-lactic acid)

Timeline

• Start date: 2004-08-01
• Completion: 2007-01-01
• First posted: 2007-03-07
• Last updated: 2019-09-18

Locations

1 site across 1 country: United States