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

Medytox

Status: Completed

Conditions: Mid Face Volume Loss

Treatments: Device: experimental; Drug: comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03754413

MT08-CN16MFV702

Details and patient eligibility

About

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

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Investigational medical device

Experimental group

Description:

Neuramis® Volume Lidocaine

Treatment:

Device: experimental

Comparator device

Other group

Description:

No-treatment

Treatment:

Drug: comparator