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Completed

NCT Number: NCT03753152

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.

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Key information

Conditions

Nasolabial Folds

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HuaShan hospital Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Experimental

Device

Neuramis® Deep Lidocaine

COMPARATOR

Device

YVOIRE® Volume Plus

Primary outcomes

  1. WSRS improvement rate at Week 24

    Time frame: Week 24

    WSRS improvement rate at Week 24

Secondary outcomes

  1. Change of WSRS from Week 4, 12, 24, 36, and 52

    Time frame: Week 4, 12, 24, 36, and 52

    Change of WSRS from Week 4, 12, 24, 36, and 52

  2. WSRS improvement rate on Week 4, 12, 36, and 52

    Time frame: Week 4, 12, 36, and 52

    WSRS improvement rate on Week 4, 12, 36, and 52

  3. GAIS improvement rate on Week 4, 12, 24, 36, and 52

    Time frame: Week 4, 12, 24, 36, and 52

    GAIS improvement rate on Week 4, 12, 24, 36, and 52

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 26, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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