NCT04855188

Brief Summary

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

April 19, 2021

Last Update Submit

December 16, 2024

Conditions

Wrinkles in the Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

  • WSRS responder rate

    the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score

    24 weeks after the last injection

Study Arms (2)

YVOIRE Y-Solution 540

EXPERIMENTAL
Device: YVOIRE Y-Solution 540

YVOIRE volume plus

ACTIVE COMPARATOR
Device: YVOIRE volume plus

Interventions

YVOIRE Y-Solution 540DEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

YVOIRE Y-Solution 540
YVOIRE volume plusDEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

YVOIRE volume plus

Eligibility Criteria

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

You may qualify if:

  • (moderate) or 4 (severe) on the 5-graded WSRS
  • who sign the written informed consent form

You may not qualify if:

  • who have received permanent facial implants
  • who have received semi-permanent fillers
  • who have undergone temporary dermal filler treatment within 12 months
  • who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
  • who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 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

April 19, 2021

First Posted

April 22, 2021

Study Start

July 1, 2021

Primary Completion

September 29, 2022

Study Completion

July 14, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

CN(1)