Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2023-01-09

Brief Summary

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A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

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Detailed Description

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This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

Conditions

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Jaw Volume Deficit

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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Test group

Hyaluronic acid dermal filler at Week 0

Group Type EXPERIMENTAL

YVOIRE Y-Solution 720

Intervention Type DEVICE

Hyaluronic acid dermal filler

Control group

Remain untreated until Week 26

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 - 75 years of age (inclusive)
* 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS)
* want a filler injection procedure for the replacement of volume loss in the jawlines

Exclusion Criteria

* have an active or infective skin disease
* have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have a tattoo or excessive facial hair in the evaluation area
* have received permanent facial implants
* have undergone semi-permanent filler within 24 months
* have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months
* have streptococcal disease
* have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid
* have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products
* have history of bleeding disorder
* have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion
* have known malignant tumors or cancerous or precancerous lesion
* positive pregnancy test indicating pregnancy
* active COVID-19 infection and suspected COVID-19 infection within the past 14 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes