Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold

Study Overview
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Brief Summary
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- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial

Detailed Description
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Subjects:Adults with nasolabial fold Investigational Devices: Study Device: SkinPlus-Hyal® Comparator Device: Restylane® - Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy

Official Title
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Clinical Trial to Evaluate the Safety and Efficacy of SkinPlus-Hyal® as Tissue Restorative Biomaterials in the Improvement of Bilateral Nasolabial Fold Wrinkles

Conditions
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Wrinkle

Intervention / Treatment
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* Device: SkinPlus-Hyal®
* Device: Restylane®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged over 20 Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric Subjects who voluntarily decided the participation of the study and signed the informed consent Subjects who agree contraception Exclusion Criteria: Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face Subjects who have a skin disorder on the NLF area Subjects who had permanent implants for dermal augmentation at the NLF area Subjects who had a history of keloid formation or hypertrophic scar Subjects who participated in other clinical trial within 3 months from screening date Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial Subjects who is Drug abuser or alcoholism Subjects who had previous treatment with Botox within 6 months from screening date Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator Subjects who had antigen of HIV or type-B Hepatitis Subjects who had anti-coagulant therapy within 2 weeks from the screening date Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Restylane®<br>Inject Restylane® on right or left nasolabial fold | Device: Restylane®<br>* The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.<br>|
| Experimental: SkinPlus-Hyal®<br>Inject SkinPlus-Hyal® on right or left nasolabial fold | Device: SkinPlus-Hyal®<br>* The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in WSRS of the test group and control group | The change in WSRS of the test group and control group from baseline at 24 weeks as assessed by the Investigator in charge of photographic assessment | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in WSRS of the test and control groups | The change in WSRS of the test and control groups from baseline at 2, 8, 16, 24 weeks as assessed by the Investigator | baseline and 2, 8, 16, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue restorative biomaterial, Hyaluronic acid, Restylane®, Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS), Nasolabial fold(NLF)