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

Not Applicable

Completed

• Conditions: Nasolabial Folds
• Interventions: Device: experimental; Device: comparator

• Registration Number: NCT03753152
• Lead Sponsor: Medy-Tox

Brief Summary

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.

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 Timeline

• Study Start: 2018-04-02
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-26
• Primary Completion: 2019-04-02
• Study Completion: 2019-10-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational medical device	experimental	Neuramis® Deep Lidocaine
Comparator device	comparator	YVOIRE® Volume Plus

Primary Outcome Measures

Name	Time	Method
WSRS improvement rate at Week 24	Week 24	WSRS improvement rate at Week 24

Secondary Outcome Measures

Name	Time	Method
GAIS improvement rate on Week 4, 12, 24, 36, and 52	Week 4, 12, 24, 36, and 52	GAIS improvement rate on Week 4, 12, 24, 36, and 52
WSRS improvement rate on Week 4, 12, 36, and 52	Week 4, 12, 36, and 52	WSRS improvement rate on Week 4, 12, 36, and 52
Change of WSRS from Week 4, 12, 24, 36, and 52	Week 4, 12, 24, 36, and 52	Change of WSRS from Week 4, 12, 24, 36, and 52

Trial Locations

Locations (1)

HuaShan hospital Fudan University; 🇨🇳 Shanghai, China