Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444353
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2007-03-05
Brief Title:
DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles Long Term Follow-up
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
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
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being undertaken to
evaluate the degree of correction attainable with DL6049 injectable poly-L-lactic acidcompared 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 acidcompared 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
evaluate the degree of correction attainable with DL6049 injectable poly-L-lactic acidcompared 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 acidcompared 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None