Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414544
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2006-12-20
Brief Title:
Evaluation of the Safety and Efficacy of CosmetaLife for the Correction of Nasolabial Folds
Sponsor:
Cosmeta
Organization:
Cosmeta
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Comparison of the Safety and Efficacy of CosmetaLife Versus Control for the Correction of Nasolabial Folds
Status:
COMPLETED
Status Verified Date:
2011-06
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 is a randomized double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds such as nasolabial folds ie smile lines
Detailed Description:
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face split face design Each subject will serve as his or her own control allowing for comparison of the outcome between the contralateral sides Patients will be followed at 2 weeks and 3 6 9 and 12 months post treatment for assessment of safety and effectiveness
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