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CompletedNCT03753152Updated Jul 28, 2020

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

An interventional study of experimental and comparator in Nasolabial Folds, sponsored by Medy-Tox. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Medy-Tox · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nasolabial Folds
03

In context

Lead sponsor

Medy-Tox is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
370 participants (actual)

Study arms

  • Experimental
    Investigational medical device

    Neuramis® Deep Lidocaine

    Device: experimental

  • Active comparator
    Comparator device

    YVOIRE® Volume Plus

    Device: comparator

Interventions

  • Deviceexperimental

    Neuramis® Deep Lidocaine

  • Devicecomparator

    YVOIRE® Volume Plus

06

What researchers measure

Primary outcomes

  1. WSRS improvement rate at Week 24

    WSRS improvement rate at Week 24

    Time frame: Week 24

Secondary outcomes

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

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

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

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

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

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

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

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

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

07

Study locations

1 site
  • HuaShan hospital Fudan University
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03753152
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Nov 26, 2018
Start date
Apr 2, 2018
Primary completion
Apr 2, 2019
Completion
Oct 16, 2019
Last update
Jul 28, 2020

Study contacts

Jinhua XU
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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