Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus

Study Overview
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Brief Summary
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This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds

Official Title
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A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds

Conditions
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Correction of Nasolabial Folds

Intervention / Treatment
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* Device: Dermalax Implant Plus
* Device: Restylane Sub-Q


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects no younger than 30 and no more than 75 years of age. Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*) *The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4. Subjects who have symmetric nasolabial folds. Exclusion Criteria: Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day) Subjects who have a history of bleeding disorder. Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermalax Implant Plus<br>Subject injected in the nasolabial folds of one side of the face in the initial treatment period. | Device: Dermalax Implant Plus<br>* Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.<br>Device: Restylane Sub-Q<br>* Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.<br>|
| Active Comparator: Restylane Sub-Q<br>Subject injected in the nasolabial folds of one side of the face in the initial treatment period. | Device: Dermalax Implant Plus<br>* Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.<br>Device: Restylane Sub-Q<br>* Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group | Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos. | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group | Improvement of wrinkle severity system scale(WSRS) scores at week2, week8, week 16, week 24 compared to baseline by independent evaluator using photos. | baseline, at week 2 24 | 
| Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved | Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved at week2, week 8, week 12, week 16, week 24 evaluated by investigator at site | at week 2 24 | 
| 100 mm visual analogue scale (VAS) scores evaluation | 100 mm visual analogue scale (VAS) scores at both nasolabial folds evaluated by subjects at application of the devices | week 0 |