Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus... | NCT03753152

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

NCT03753152

Sponsor

Medy-Tox

Status

Completed

Last Update Posted

Jul 28, 2020Actual

Enrollment

370Actual

Phase

Not Applicable

Conditions

Nasolabial Folds

Interventions

experimental
comparator

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2018Actual

Primary Completion Date

Apr 2, 2019Actual

Completion Date

Oct 16, 2019Actual

First Submitted Date

Nov 22, 2018

First Submission Date that Met QC Criteria

Nov 22, 2018

First Posted Date

Nov 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

370Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational medical device	Experimental	Neuramis® Deep Lidocaine	Device: experimental
Comparator device	Active Comparator	YVOIRE® Volume Plus	Device: comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
experimental	Device	Neuramis® Deep Lidocaine	Investigational medical device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinhua XU	Huashan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HuaShan hospital Fudan University		Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided