Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds

Study Overview
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Brief Summary
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The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.

Official Title
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Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds: Single Center, Prospective, Comparative, Randomized, Double Blinded (Subject, Evaluator), Matched Pairs Design, Non-inferiority, Pivotal Clinical Trial

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: DKM-410
* Device: Juvederm ULTRA PLUS XC 1.0ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 years and older Wrinkle Severity Rating Scale (WSRS) 3 or 4 Visually symmetrical bilateral nasolabial folds Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics. Voluntarily decided to participate in the study and signed the informed consent form Willing to follow the protocol Exclusion Criteria: History of undergoing a permanent or semi-permanent filler treatment on the face Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening. Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein Hypersensitivity to Lidocaine or amide local anesthetic Positive for the intradermal response test History of severe or plurality of allergies Having skin inflammation or infection in nasolabial folds History of keloid formation, hyperpigmentation, or hypertrophic scars on the face. History of streptococcal disease Uncontrolled epilepsy Porphyria Having or being currently suffering from autoimmune diseases History of immunodeficiency or immunosuppressive drugs History of herpetic eruption Having bleeding disorder or blood clotting disorder Having anticoagulant drugs or components within 72 hours from the application of medical advice Received antiplatelet drugs within 2 weeks from the application of medical advice Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice Received drugs that inhibit or decrease liver metabolism Clinically significant abnormalities on electrocardiogram Pregnant or breast-feeding or who planning to conceive Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness Other investigational products or procedures within 3 months from screening Not eligible due to other reasons at the investigator's discretion

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DKM-410<br>Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline | Device: DKM-410<br>* Injection up to 2.0ml<br>|
| Active Comparator: Juvederm ULTRA PLUS XC 1.0ml<br>Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline | Device: Juvederm ULTRA PLUS XC 1.0ml<br>* Injection up to 2.0ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24. | Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48. | WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme. | Baseline and Weeks 8, 16 and 48. | 
| Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48. | The percentage of subjects whose WSRS score was lowered by 1 or more points. | Baseline and Weeks 8, 16, 24 and 48. | 
| Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48. | WSRS(Wrinkle Severity Rating Scale) grading scale from 1 to 5, with grade 1 as absent, grade 2 as mild, grade 3 as moderate, grade 4 as severe, grade 5 as extreme. | Baseline and Weeks 8, 16, 24 and 48. | 
| Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48. | The percentage of subjects whose WSRS score was lowered by 1 or more points. | Baseline and Weeks 8, 16, 24 and 48. | 
| Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48. | Global Aesthetic Improvement Scale (GAIS) from -1 to 3, with grade -1 as worse, grade 0 as no change, grade 1 as improved, grade 2 as much improved, grade 3 as very much improved. | Baseline and Weeks 8, 16, 24 and 48. | 
| Visual Analog Scale (VAS) after the treatment. | Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain. | Baseline |