Ignite Creation Date:
2025-12-17 @ 3:31 PM
Ignite Modification Date:
2025-12-23 @ 6:50 PM
Study NCT ID:
NCT00764257
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2008-10-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PREVELLE Shape (CX002) Dermal Filler Protocol
Sponsor:
Mentor Worldwide, LLC
Organization:
Study Overview
Official Title:
A Multicenter, Evaluator-Masked Study to Assess the Efficacy and Safety of Mentor's CX002 Dermal Filler Medical Device, When Applied as an Intradermal Implant for the Correction of Facial Wrinkles and Lip Augmentation (CX002 Dermal Filler Protocol)
Status:
COMPLETED
Status Verified Date:
2011-12
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:
The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: