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

Medy-Tox236 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

236

Conditions

Mid Face Volume Loss

Interventions

experimentalDEVICE

Neuramis® Deep Lidocaine

comparatorDRUG

No-treatment

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Hopsital

Beijing, China

Outcomes

Primary Outcomes

Total Facial Volume Scale(FVS) improvement rate at 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

Time frame: Week 24

Secondary Outcomes

6-point Facial Volume Scale(FVS) improvement rate at 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.

Time frame: Weeks 4, 12, 36, and 52

Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52

Time frame: Weeks 4, 12, 24, 36, and 52

Global Aesthetic Improvement Scale(GAIS) improvement rate at 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

Time frame: Weeks 4, 12, 24, 36, and 52

Data from ClinicalTrials.gov

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