To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

Study Overview
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Brief Summary
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Investigational Device : HARA (Hyaluronic Acid Filler) Title : A Single center, Randomized, Subject & Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds

Official Title
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A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

Conditions
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Nasolabial FOLD

Intervention / Treatment
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* Device: HARA Filler(Hyaluronic acid Filler)
* Device: Restylane® Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who agreed to this treatment and signed the Informed Consent Form Those who are 19 years old or more and desire to take correction of nasolabial folds Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least Exclusion Criteria: Those who are sensitive to lidocaine or other amide anesthesia Those who are sensitive to control device Those who are pregnant or lactating, or expect pregnancy Those who are judged by the subinvestigator to be improper for this study

Ages Eligible for Study
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Minimum Age: 19 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Device Group(HARA filler)<br> | Device: HARA Filler(Hyaluronic acid Filler)<br>* The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).<br>|
| Active Comparator: Comparator Group(Restylane® Lidocaine)<br> | Device: Restylane® Lidocaine<br>* The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment By independent evaluator | Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale) * Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme | Week 24 From baseline Visit(=Investigational Device Injection) |