Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-13
Brief Title:
Polymeric Microspheres vs Sculptra in the Treatment of Moderate to Severe Nasolabial Folds
Sponsor:
Taipei Medical University Hospital
Organization:
Taipei Medical University Hospital
Study Overview
Official Title:
A Controlled Randomized Double-Blinded Intra-Subject Multicenter Prospective Clinical Study to Investigate the Non-Inferiority Between the Polymeric Microspheres and Sculptra in the Treatment of Moderate to Severe Nasolabial Folds
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 single-dose randomized double-blind active-controlled split-face multiple centers non-inferiority study Approximately 50 nasolabial fold subjects will be enrolled Each enrolled subject will be randomized equally into one of the following groups
1 Group 1 right face will be injected with PBF PLLA microsphere and left face with Sculptra
2 Group 2 right face will be injected with Sculptra and left face with PBF PLLA microsphere Subjects will be administrated on Visit 1 by applying PBF PLLA microsphere on one side of face and Sculptra on the other
1 Group 1 right face will be injected with PBF PLLA microsphere and left face with Sculptra
2 Group 2 right face will be injected with Sculptra and left face with PBF PLLA microsphere Subjects will be administrated on Visit 1 by applying PBF PLLA microsphere on one side of face and Sculptra on the other
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None