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

Nasolabial Fold Wrinkles Clinical Trial

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)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Nasolabial Fold Wrinkles

• NCT number: NCT00444353
• Study type: Interventional
• Source: Bausch Health Americas, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: August 2004
• Completion date: January 2007