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

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

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-25

Study Completion Date

2023-11-08

Brief Summary

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

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Detailed Description

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Conditions

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Volume Defects in the Mid-face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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YVOIRE Y-Solution 720

Hyaluronic acid dermal filler

Group Type EXPERIMENTAL

YVOIRE Y-Solution 720

Intervention Type DEVICE

Hyaluronic acid dermal filler

Control

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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YVOIRE Y-Solution 720

Hyaluronic acid dermal filler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes