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

NCT ID: NCT02721368

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-03
• Study Completion Date: 2019-09-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Investigational medical device

Neuramis® Volume Lidocaine

Group Type: EXPERIMENTAL

Neuramis® Volume Lidocaine

Intervention Type: DEVICE

hyaluronic acid filler

Comparator medical device

Juvederm® Voluma® with Lidocaine

Group Type: ACTIVE_COMPARATOR

Juvederm® Voluma® with Lidocaine

Intervention Type: DEVICE

hyaluronic acid filler

Interventions

Neuramis® Volume Lidocaine

hyaluronic acid filler

Intervention Type: DEVICE

Juvederm® Voluma® with Lidocaine

hyaluronic acid filler

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject aged between 35 and 65.

2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

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 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>

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BeomJoon Kim

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang Univ. Medical Center

Locations

Chung-Ang Univ. Medical Center

Seoul, Dongjak-gu, South Korea

Countries

South Korea

Other Identifiers

MT_PRT_MVD01

Identifier Type: -

Identifier Source: org_study_id