Efficacy and Safety Evaluation Study of Neuramis® Deep Lidocaine in Correction of Nasolabial Fold

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of the study medical device, Neuramis® Deep Lidocaine and the control medical device, Restylane® PERLANE-L in correction of nasolabial folds

Detailed Description
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This study is a multi-center, double blind, intra-individual controlled, active-controlled clinical trial. Efficacy and Safety are evaluated at the appointed time at subject visit clinical site after Injecting medical device.

Official Title
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A Randomized, Multi-center, Double Blind, Intra-Individual Controlled, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis® Deep Lidocaine as Compared to Restylane® PERLANE-L in Correction of Nasolabial Fold

Conditions
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Nasolabial Fold

Intervention / Treatment
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* Device: Neuramis® Deep Lidocaine
* Device: Restylane® PERLANE-L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged between 30 and 70 years, inclusive Subjects who want improvement of bilateral nasolabial folds that are rated as 3 or 4 points on Wrinkle Severity Rating Scale Subjects with visually symmetrical bilateral nasolabial folds Subjects who consent to abstain from wrinkle improvement treatment in the lower face (below the lower orbital rim) during this trial Subjects who are capable of understanding and following instructions, and participating in the entire course of the trial Subjects who voluntarily decide to participate in this trial and provide written consent in the Informed Consent Form Exclusion Criteria: Subjects who administered an anticoagulant (except for low-dose aspirin (100mg, up to 300mg/day) or equivalent) within 2 weeks prior to screening Subjects who had face-lift, soft tissue augmentation, medium or deeper peeling, or dermal photo-rejuvenation on the lower face (lower orbital rim) for wrinkle improvement within 6 months prior to screening Subjects who received treatment with calcium hydroxyapatite(CaHA) at the investigational medical device injection site within 1 year from screening Subjects who have implanted a permanent expander prosthesis at the investigational medical device injection site, such as soft-form or silicon Subjects with a scar or skin lesion at the investigational medical device injection site that may interfere with judgment of the treatment effect Subjects with a history of anaphylaxis or severe complicated allergy or allergy to lidocaine or hyaluronic acid products Subjects with a history of a hypertrophic scar or keloid Subjects with a skin disease or wound infection at the investigational medical device injection site Subjects who participated in another clinical trial within 30 days prior to screening Pregnant or breastfeeding women or women of childbearing potential who are not using medically acceptable contraception or not consenting to practice birth control from screening to the end of trial Subjects who are otherwise determined by the investigator as ineligible for this study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuramis® Deep Lidocaine<br>Neuramis® Deep Lidocaine Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection | Device: Neuramis® Deep Lidocaine<br>* HA filler<br>|
| Active Comparator: Restylane® PERLANE-L<br>Restylane® PERLANE-L Hyaluronic Acid Gel and Lidocaine Hydrochlorid, total dose 1ml, single injection | Device: Restylane® PERLANE-L<br>* HA filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on the Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs |  | from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Wrinkle Severity Rating Scale as evaluated by an investigator |  | from baseline to 8, 16, 24 weeks | 
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by an investigator |  | from baseline to 8, 16, 24 weeks | 
| Change on Wrinkle Severity Rating Scale as evaluated by photograph raters using photographs |  | from baseline to 8, 16 weeks | 
| Proportion of subjects with a ≥ 1 point change on Wrinkle Severity Rating Scale as evaluated by photograph raters |  | from baseline to 8, 16, 24 weeks | 
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by an investigator |  | 8, 16, 24 weeks after the injection | 
| Proportion of subjects with a ≥ 1 point on Global Aesthetic Improvement Scale as evaluated by a subject |  | 8, 16, 24 weeks after the injection | 
| Visual Analogue Scale as evaluated by a subject |  | at 15, 30, 45, 60 minutes after the injection | 
| Vital signs, physical examination, laboratory tests and adverse events |  | from baseline to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrinkle Severity Rating Scale, Global Aesthetic Improvement Scale, Hyaluronic acid filler, filler, Nasolabial Fold