Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

Medytox

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: experimental; Device: comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03753152

MT07-CN16NLF701

Details and patient eligibility

About

This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Full description

Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Enrollment: 370 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female, 18 to 75 years of age.
2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

Exclusion criteria

1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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370 participants in 2 patient groups

Investigational medical device

Experimental group

Description:

Neuramis® Deep Lidocaine

Treatment:

Device: experimental

Comparator device

Active Comparator group

Description:

YVOIRE® Volume Plus

Treatment:

Device: comparator