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To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

NCT ID: NCT04784299

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2022-10-26

Brief Summary

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A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

Detailed Description

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This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Conditions

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Midface Volume Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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YVOIRE volume plus

Hyaluronic acid dermal filler

Group Type EXPERIMENTAL

YVOIRE volume plus

Intervention Type DEVICE

Hyaluronic acid dermal filler

Restylane Lyft with Lidocaine

Hyaluronic acid dermal filler

Group Type ACTIVE_COMPARATOR

Restylane Lyft with Lidocaine

Intervention Type DEVICE

Hyaluronic acid dermal filler

Interventions

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YVOIRE volume plus

Hyaluronic acid dermal filler

Intervention Type DEVICE

Restylane Lyft with Lidocaine

Hyaluronic acid dermal filler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female aged between 21 to 75 years (inclusive)
* 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
* Desire cheek augmentation to correct volume deficit in the midface.
* Agree to use contraception
* Sign Informed Consent Form

Exclusion Criteria

* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
* have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
* have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
* have history of bleeding disorder
* have a tendency to develop hypertrophic scarring or keloid
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Investigator

Role: PRINCIPAL_INVESTIGATOR

LG Chem Investigational site 01

Locations

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LG Chem investigational site 01

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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LG-HACL029

Identifier Type: -

Identifier Source: org_study_id