Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 4:36 PM
Study NCT ID:
NCT02751034
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold
Sponsor:
Medy-Tox
Organization:
Study Overview
Official Title:
A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold
Status:
COMPLETED
Status Verified Date:
2016-04
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 is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds
Detailed Description:
This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.
Study Oversight
Has Oversight DMC:
False
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?: