Nasolabial Folds
Conditions
Brief summary
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.
Interventions
DEVICEDKM-410
Injection up to 2.0ml
DEVICEJuvederm ULTRA PLUS XC 1.0ml
Injection up to 2.0ml
Sponsors
Dongkook Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 19 years and older 2. Wrinkle Severity Rating Scale (WSRS) 3 or 4 3. Visually symmetrical bilateral nasolabial folds 4. Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics. 5. Voluntarily decided to participate in the study and signed the informed consent form 6. Willing to follow the protocol
Exclusion criteria
1. History of undergoing a permanent or semi-permanent filler treatment on the face 2. Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening. 3. Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening 4. History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein 5. Hypersensitivity to Lidocaine or amide local anesthetic 6. Positive for the intradermal response test 7. History of severe or plurality of allergies 8. Having skin inflammation or infection in nasolabial folds 9. History of keloid formation, hyperpigmentation, or hypertrophic scars on the face. 10. History of streptococcal disease 11. Uncontrolled epilepsy 12. Porphyria 13. Having or being currently suffering from autoimmune diseases 14. History of immunodeficiency or immunosuppressive drugs 15. History of herpetic eruption 16. Having bleeding disorder or blood clotting disorder 17. Having anticoagulant drugs or components within 72 hours from the application of medical advice 18. Received antiplatelet drugs within 2 weeks from the application of medical advice 19. 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 20. Received drugs that inhibit or decrease liver metabolism 21. Clinically significant abnormalities on electrocardiogram 22. Pregnant or breast-feeding or who planning to conceive 23. Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness 24. Other investigational products or procedures within 3 months from screening 25. Not eligible due to other reasons at the investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in WSRS(Wrinkle Severity Rating Scale) score by independent evaluators from Baseline to Week 24. | Baseline and Week 24 | Independent evaluators evaluate the WSRS score change at Week 24 compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of treatment(N%) by investigator from Baseline to Weeks 8, 16, 24 and 48. | Baseline and Weeks 8, 16, 24 and 48. | The percentage of subjects whose WSRS score was lowered by 1 or more points. |
| Global Aesthetic Improvement Scale (GAIS) from Baseline to Weeks 8, 16, 24 and 48. | Baseline and 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. |
| Change in Wrinkle Severity Rating Scale(WSRS) score by investigator from Baseline to Weeks 8, 16, 24 and 48. | Baseline and 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. |
| Success rate of treatment(N%) by independent evaluators from Baseline to Weeks 8, 16, 24 and 48. | Baseline and Weeks 8, 16, 24 and 48. | The percentage of subjects whose WSRS score was lowered by 1 or more points. |
| Visual Analog Scale (VAS) after the treatment. | Baseline | Visual Analog Scale (VAS) from 0mm to 100mm, with 0mm as no pain, 100mm as maximum pain. |
| Change in Wrinkle Severity Rating Scale(WSRS) score by independent evaluators from Baseline to Weeks 8, 16 and 48. | Baseline and 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. |
Countries
South Korea
Outcome results
None listed