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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721368
• Other study ID #: MT_PRT_MVD01
• Status: Completed
• Phase: N/A
• Start date: November 3, 2016
• Est. completion date: September 11, 2019

Study information

• Verified date: October 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 11, 2019
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Device:
• Neuramis® Volume Lidocaine
hyaluronic acid filler
• Juvederm® Voluma® with Lidocaine
hyaluronic acid filler

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang Univ. Medical Center	Seoul	Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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