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

A Multicenter Randomized, Evaluator-Blinded, Active Controlled Design Study to Evaluate the Safety and Effectiveness of Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

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.

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: experimental; Device: comparator

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational medical device; Neuramis® Deep Lidocaine	Device: experimental; Neuramis® Deep Lidocaine
Active Comparator: Comparator device; YVOIRE® Volume Plus	Device: comparator; YVOIRE® Volume Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WSRS improvement rate at Week 24	WSRS improvement rate at Week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of WSRS from Week 4, 12, 24, 36, and 52	Change of WSRS from Week 4, 12, 24, 36, and 52	Week 4, 12, 24, 36, and 52
WSRS improvement rate on Week 4, 12, 36, and 52	WSRS improvement rate on Week 4, 12, 36, and 52	Week 4, 12, 36, and 52
GAIS improvement rate on Week 4, 12, 24, 36, and 52	GAIS improvement rate on Week 4, 12, 24, 36, and 52	Week 4, 12, 24, 36, and 52

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Principal Investigator: Jinhua Xu, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MT07-CN16NLF701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No