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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754413
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Study Description
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Brief Summary:
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

Condition or disease Intervention/treatment Phase
Mid Face Volume Loss Device: experimental Drug: comparator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : March 9, 2020
Actual Study Completion Date : March 9, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational medical device
Neuramis® Volume Lidocaine
 Device: experimental
Neuramis® Deep Lidocaine
Comparator device
No-treatment
 Drug: comparator
No-treatment


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754413


Locations
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China
Beijing Hopsital
Beijing, China
Sponsors and Collaborators
Medy-Tox
More Information
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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03754413    
Other Study ID Numbers: MT08-CN16MFV702
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No