NCT03754413

Brief Summary

To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

November 22, 2018

Last Update Submit

March 17, 2021

Conditions

Mid Face Volume Loss

Outcome Measures

Primary Outcomes (1)

  • Total Facial Volume Scale(FVS) improvement rate at Week 24

    Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline

    Week 24

Secondary Outcomes (3)

  • 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52

    Weeks 4, 12, 36, and 52

  • Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52

    Weeks 4, 12, 24, 36, and 52

  • Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52

    Weeks 4, 12, 24, 36, and 52

Study Arms (2)

Investigational medical device

EXPERIMENTAL

Neuramis® Volume Lidocaine

Device: experimental

Comparator device

OTHER

No-treatment

Drug: comparator

Interventions

experimentalDEVICE

Neuramis® Deep Lidocaine

Investigational medical device
comparatorDRUG

No-treatment

Comparator device

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 20 to 75 years of age
  • Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale

You may not qualify if:

  • Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs.
  • Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hopsital

Beijing, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 27, 2018

Study Start

May 29, 2018

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

CN(1)