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

Not Applicable

Completed

• Conditions: Aging

• Registration Number: NCT02721368
• Lead Sponsor: Medy-Tox

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.

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Study Start: 2016-11-03
• Primary Completion: 2017-10-31
• Study Completion: 2019-09-11
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)	104 weeks	Primary outcome for extension study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chung-Ang Univ. Medical Center; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of