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Completed

NCT Number: NCT03754413

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

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

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Key information

Conditions

Mid Face Volume Loss

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hopsital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female 20 to 75 years of age
  • 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

  • Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
  • 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.

Treatment and study plan

Experimental

Device

Neuramis® Deep Lidocaine

Comparator

Drug

No-treatment

Primary outcomes

  1. Total Facial Volume Scale(FVS) improvement rate at Week 24

    Time frame: 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 outcomes

  1. 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52

    Time frame: 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.

  2. 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

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

  3. Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Multicenter Randomized, Evaluator-Blinded, "No Treatment" Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Mar 19, 2021

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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