NCT02721368

Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume

Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Detailed description

This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Conditions

• Aging

Interventions

Type	Name	Description
DEVICE	Neuramis® Volume Lidocaine	hyaluronic acid filler
DEVICE	Juvederm® Voluma® with Lidocaine	hyaluronic acid filler

Timeline

• Start date: 2016-11-03
• Primary completion: 2017-10-31
• Completion: 2019-09-11
• First posted: 2016-03-29
• Last updated: 2020-10-14

Locations

1 site across 1 country: South Korea