NCT03753152

Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Detailed description

Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	experimental	Neuramis® Deep Lidocaine
DEVICE	comparator	YVOIRE® Volume Plus

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-04-02
• Completion: 2019-10-16
• First posted: 2018-11-26
• Last updated: 2020-07-28

Locations

1 site across 1 country: China