A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

Study Overview
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Brief Summary
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A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.

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 Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.

Official Title
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A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

Conditions
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Correction of Nasolabial Folds

Intervention / Treatment
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* Device: Hyaluronic acid dermal filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 21 years or above age. 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale). Agree to use proper contraception as guided in the protocol. Signed for Informed Consent. Exclusion Criteria: have received permanent facial implants anywhere in the face or neck or planning during the investigation. have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks have undergone semi-permanent filler in lower face have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days

Ages Eligible for Study
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Minimum Age: 21 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 Classic plus<br> | Device: Hyaluronic acid dermal filler<br>* Hyaluronic acid dermal filler used for facial volume or wrinkle correction<br>|
| Active Comparator: Restylane Lidocaine<br> | Device: Hyaluronic acid dermal filler<br>* Hyaluronic acid dermal filler used for facial volume or wrinkle correction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24. | To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme). | 24 weeks from baseline | 
| Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24. | To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated. | 24 weeks from baseline |