Clinical Trial of YYD701-2 for Treatment of Nasolabial Folds

Study Overview
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Brief Summary
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A multicenter, active-controlled, randomized, evaluator and subject blinded, split-face, comparative, non-inferiority, Medical device Clinical trial. This study is randomized, evaluator and subject blinded, split-face medical device Clinical trial. The Subjects are injected investigational device(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds.

Official Title
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A Multicenter, Active-controlled, Randomized, Evaluator and Subject Blinded, Split-face, Comparative, Non-inferiority and Confirmatory Clinical Study of the Efficacy and Safety Between YYD701-2 and Restylane Perlane Lidocaine for Temporary Correction of Moderate to Severe Nasolabial Folds

Conditions
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Wrinkle Severity Rating Scale(WSRS) Grade 3 (Moderate) or 4 (Severe) of Nasolabial Folds

Intervention / Treatment
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* Device: YYD701-2
* Device: Restylane Perlane Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female aged between 30 and 75 years, inclusive Subjects who want improvement of nasolabial folds that are rated as grade 3 or 4 on Wrinkle severity rating scale(WSRS) Subjects who have visually symmetrical bilateral nasolabial folds Subjects who consent to discontinue all dermatological treatment or cure including wrinkle correction in and around infraorbital region during this trial Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form Exclusion Criteria: Subject who have bleeding disorder in the past or present Other criteria as identified in the protocol

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The Subjects are injected investigational devide(YYD701-2 or Restylane Perlane Lidocaine) in right or left nasolabial folds
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YYD701-2<br>YYD701-2 Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection | Device: YYD701-2<br>* HA Filler<br>|
| Active Comparator: Restylane Perlane Lidocaine<br>Restylane Perlane Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection | Device: Restylane Perlane Lidocaine<br>* HA Filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 2, 8, 16 weeks | 
| The change in Wrinkle Severity Rating Scale (WSRS) as evaluated by investigator. | Score of WSRS assessed by the investigator | from baseline to 2, 8, 16, 24 weeks | 
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator | Score of GAIS assessed by the investigator | 2, 8, 16, 24 weeks after week 0 (injection date) | 
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject | Score of GAIS assessed by subject | 2, 8, 16, 24 weeks after week 0 (injection date) | 
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by independent evaluator through Photographs. | Score of WSRS assessed by the independent evaluator | from baseline to 2, 8, 16, 24 weeks | 
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by the investigator | Score of WSRS assessed by the investigator | from baseline to 2, 8, 16, 24 weeks | 
| Visual Analogue Scale as evaluated by a subject | Score of VAS assessed by subject | week 0 (injection date) |