Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

Study Overview
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Brief Summary
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This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, the control preparation.

Official Title
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A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of HA IDF Versus Restylane in Nasolabial Fold Intradermal Injection

Conditions
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Temporary Correction of Wrinkles

Intervention / Treatment
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* Device: HA IDF (YVOIRE classic)
* Device: Restylane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: Women in 30 55 years. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent. Exclusion Criteria: Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy. Patients with a disorder in autoimmune system Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared). Patients with a malignant tumor Women in pregnancy or lactation Hepatitis carriers or VDRL/HIV positive patients Those with a hypersensitivity to the investigational medical device of this study Other persons including those considered as difficult to perform this study by the principal investigator

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 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
Interventional Model Description: IND approved from KFDA
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA IDF<br> | Device: HA IDF (YVOIRE classic)<br>* Treatment with HA IDF<br>|
| Active Comparator: Restylane<br> | Device: Restylane<br>* Treatment with Restylane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device | Wrinkle Severity Rating Scale (WSRS) Absent: no visible fold; continuous line Mild: Shallow but visible fold with slight indentation; minor facial feature Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone | Week 26 (Visit 7) |