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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-10-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Investigational medical device

Neuramis® Deep Lidocaine

Group Type EXPERIMENTAL

experimental

Intervention Type DEVICE

Neuramis® Deep Lidocaine

Comparator device

YVOIRE® Volume Plus

Group Type ACTIVE_COMPARATOR

comparator

Intervention Type DEVICE

YVOIRE® Volume Plus

Interventions

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experimental

Neuramis® Deep Lidocaine

Intervention Type DEVICE

comparator

YVOIRE® Volume Plus

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes