NCT02751034

Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasolabial Fold

Interventions

Type	Name	Description
DEVICE	Neuramis® Deep Lidocaine	HA filler
DEVICE	Restylane® PERLANE-L	HA filler

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2016-04-26
• Last updated: 2016-04-26

Locations

2 sites across 1 country: South Korea