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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Device: Neuramis® Volume Lidocaine; Device: Juvederm® Voluma® with Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 156-755
      • Chung-Ang Univ. Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject aged between 35 and 65.
2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

Exclusion Criteria:

1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
3. Those who has thin skin in the mid-facial area
4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics

<Extension Study>

Inclusion Criteria:

1. Participated in the pivotal study and completed the end of study visit
2. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study

Exclusion Criteria

1. Those who have following procedual history between completion of the pivotal study and entry of extension study

   - facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting

2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational medical device; Neuramis® Volume Lidocaine	Device: Neuramis® Volume Lidocaine; hyaluronic acid filler
Active Comparator: Comparator medical device; Juvederm® Voluma® with Lidocaine	Device: Juvederm® Voluma® with Lidocaine; hyaluronic acid filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)	MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.	24 weeks
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)	Primary outcome for extension study	104 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit	104 weeks
Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)	104 weeks

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: BeomJoon Kim, Chung-Ang Univ. Medical center

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): September 11, 2019

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MT_PRT_MVD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided