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Completed

NCT Number: NCT02721368

Neuramis® Volume Lidocaine Treatment in Patients With Loss of 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.

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Key information

Conditions

Aging

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang Univ. Medical Center

Seoul, Dongjak-gu, 156-755, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

<Extension Study>

Inclusion criteria

  • Participated in the pivotal study and completed the end of study visit
  • 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

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

Treatment and study plan

Neuramis® Volume Lidocaine

Device

hyaluronic acid filler

JUVEDERM® VOLUMA® with lidocaine

Device

hyaluronic acid filler

Primary outcomes

  1. Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

    Time frame: 24 weeks

    MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition.

  2. Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)

    Time frame: 104 weeks

    Primary outcome for extension study

Secondary outcomes

  1. The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit

    Time frame: 104 weeks

  2. Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)

    Time frame: 104 weeks

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 29, 2016
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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