NCT04437745

Brief Summary

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

June 16, 2020

Last Update Submit

February 7, 2024

Conditions

Volume Defects in the Mid-face

Outcome Measures

Primary Outcomes (1)

  • Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate

    the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)

    26 weeks from baseline

Study Arms (2)

YVOIRE Y-Solution 720

EXPERIMENTAL

Hyaluronic acid dermal filler

Device: YVOIRE Y-Solution 720

Control

NO INTERVENTION

No Intervention

Interventions

YVOIRE Y-Solution 720DEVICE

Hyaluronic acid dermal filler

YVOIRE Y-Solution 720

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults 18 to 65 years of age (inclusive)
  • (moderate) or 4 (severe) on MFVDA-SRS
  • sign the written informed consent form

You may not qualify if:

  • have streptococcal disease or bleeding disorder
  • have an active or infective skin disease, scars, or tumor on mid-face
  • have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
  • have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
  • have a medical history of hypertrophic cicatrix or keloid
  • have radiation therapy experience on mid-face
  • have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

  • Xiaojun Wang

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

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

June 16, 2020

First Posted

June 18, 2020

Study Start

November 25, 2020

Primary Completion

December 13, 2022

Study Completion

November 8, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

CN(1)