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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
hyaluronic acid filler
hyaluronic acid filler
Chung-Ang Univ. Medical Center
Seoul, Dongjak-gu, South Korea
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.
Time frame: 24 weeks
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
Time frame: 104 weeks
The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit
Time frame: 104 weeks
Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS)
Time frame: 104 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.