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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753152
• Other study ID #: MT07-CN16NLF701
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: October 16, 2019

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 16, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• experimental
Neuramis® Deep Lidocaine
• comparator
YVOIRE® Volume Plus

Locations

Country	Name	City	State
China	HuaShan hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WSRS improvement rate at Week 24	WSRS improvement rate at Week 24	Week 24
Secondary	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
Secondary	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
Secondary	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