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

NCT02721368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-10-14

No results posted yet for this study

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.

Conditions

  • Aging

Interventions

DEVICE

Neuramis® Volume Lidocaine

hyaluronic acid filler

DEVICE

Juvederm® Voluma® with Lidocaine

hyaluronic acid filler

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Principal Investigators

  • BeomJoon Kim · Chung-Ang Univ. Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2017-10-31
Completion
2019-09-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02721368 on ClinicalTrials.gov