Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face

Not Applicable

Completed

• Conditions: Mid Face Volume Loss
• Interventions: Device: experimental; Drug: comparator

• Registration Number: NCT03754413
• Lead Sponsor: Medy-Tox

Brief Summary

To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

Detailed Description

This is a multicenter, randomized, evaluator-blinded, "no-treatment" controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

1. Male or female 20 to 75 years of age
2. Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale

Exclusion Criteria

1. Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
2. Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational medical device	experimental	Neuramis® Volume Lidocaine
Comparator device	comparator	No-treatment

Primary Outcome Measures

Name	Time	Method
Total Facial Volume Scale(FVS) improvement rate at Week 24	Week 24	Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline

Secondary Outcome Measures

Name	Time	Method
6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52	Weeks 4, 12, 36, and 52	The proportion of subjects with 6-point Facial Volume Scale(FVS) decrease ≥1 from Baseline as assessed at Weeks 4, 12, 36, and 52.
Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52	Weeks 4, 12, 24, 36, and 52	Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52
Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52	Weeks 4, 12, 24, 36, and 52	Global Aesthetic Improvement Scale(GAIS) improvement rate is defined as the proportion of subjects with GAIS score ≤3

Trial Locations

Locations (1)

Beijing Hopsital; 🇨🇳 Beijing, China