To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

Study Overview
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Brief Summary
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A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

Detailed Description
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This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area

Official Title
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A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area.

Conditions
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Lip Augmentation

Intervention / Treatment
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* Device: YVOIRE Y-Solution 360
* Device: Juvéderm VOLBELLA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years or above age. 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale). Agree to use proper contraception as guided in the protocol. Signed for Informed Consent. Exclusion Criteria: have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities have undergone oral surgery within 6 weeks have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products have undergone semi-permanent filler in lower face within 24 months have undergone temporary dermal filler treatment in the lower face within 12 months Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months have used lip plumping products within 10 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YVOIRE Y-Solution 360<br>Hyaluronic acid dermal filler | Device: YVOIRE Y-Solution 360<br>* Hyaluronic acid dermal filler<br>|
| Active Comparator: Juvéderm VOLBELLA<br>Hyaluronic acid dermal filler | Device: Juvéderm VOLBELLA<br>* Hyaluronic acid dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12. | To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced). | 12 weeks from baseline | 
| Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12. | To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated. | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). | 2, 4, 12, 24 weeks from baseline | 
| Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the responder rate (defined as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). | 2, 4, 12, 24 weeks from baseline | 
| Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS). | 2, 4, 12, 24 weeks from baseline | 
| Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the responder rate (as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS). | 2, 4, 12, 24 weeks from baseline | 
| Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator. | To measure the satisfaction of YVOIRE Y-Solution 360 the GAIS evaluation will be performed by subject and investigator. GAIS Grade are -2 (Much Worse), -1 (Worse), 0 (No change), 1 (Improved), and 2 (Much improved). | 2, 4, 12, 24 weeks from baseline |