Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

Study Overview
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Brief Summary
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This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subeject diary and follow up visits.

Official Title
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A Randomized, Multi-center, Double Masked, Matched Pairs, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis as Compared to Restylane® in Correction of Nasolabial Fold

Conditions
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Nasolabial Fold

Intervention / Treatment
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* Device: HA filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged between 30 and 75 Subjects who wanting to correct his/her nasolabial fold and attaining grade 3 or 4 in the Wrinkle Severity Rating Scale(WSRS) of nasolabial fold Subjects whose nasolabial folds are visually symmetric Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study Subjects who can understand and comply with the instructions and all visit schedule Subjects who voluntarily decided the participation of the study and signed the informed consent Exclusion Criteria: Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date Subjects who had previous treatment at the lower orbital rim for wrinkle correction(e.g., face lift, soft tissue augmentation, medium depth peels, dermal photorejuvenation) within 6 months from screening date Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid Subjects who had a history of keloid formation or hypertrophic scar Subjects who have a skin disorder or wound infection in the NLF area Subjects who participated in other clinical trial within 30 days from screening date The childbearing subjects who disagreed with medically acceptable contraception(e.g., condom, oral contraceptives continuing at least 3 months, contraceptives for injection or insertion, intrauterine contraceptive devices) Pregnant or lactating subjects Patients who are not eligible for this study at the medical discretion of the investigator

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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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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuramis<br> | Device: HA filler<br>* The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.<br>|
| Active Comparator: Restylane®<br> | Device: HA filler<br>* The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS | The change between baseline and 24 weeks WSRS evaluated by the investigator in charge of live assessment | 24 weeks after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS | The change between baseline and 2, 8, 16, 24 week WSRS evaluated by the investigator in charge of photographic assessment | 2, 8, 16, 24 weeks after the injection | 
| WSRS | The change between baseline and 2, 8, 16 week WSRS evaluated by the investigator in charge of live assessment | 2, 8, 16 weeks after the injection | 
| GAIS | The rate of subjects whose GAIS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks from the injection | 2, 8, 16, 24 weeks after the injection | 
| GAIS | The rate of subjects whose GAIS, evaluated by the subjects him/herselves, is 1 point or above after 2, 8, 16, 24 weeks from the injection | 2, 8, 16, 24 weeks after the injection | 
| WSRS | The rate of subjects whose change of WSRS, evaluated by the investigator in charge of live assessment, is 1 point or above after 2, 8, 16, 24 weeks of the injection | 2, 8, 16, 24 weeks after the injection | 
| WSRS | The rate of subjects whose change of WSRS, evaluated by the investigator in charge of photographic assessment, is 1 pointe or above after 2, 8, 16, 24 weeks of the injection | 2, 8, 16, 24 weeks after the injection | 
| Number of adverse events in subjects | Adverse events occured after informed consent, Adverse drug events, Serious adverse events, lab test, physical examination, vital signs | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WSRS, GAIS, HA filler, filler