Effectiveness and Safety of YVOIRE Y-Solution 540

May 25, 2022 updated by: LG Chem

A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: YVOIRE Y-Solution 540
Device: YVOIRE Y-Solution 540
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
Active Comparator: YVOIRE volume plus
Device: YVOIRE volume plus
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WSRS responder rate
Time Frame: 24 weeks after the last injection
the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score
24 weeks after the last injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LG-HACL027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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