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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DKM-410 | Experimental | Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline |
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| Juvederm ULTRA PLUS XC 1.0ml | Active Comparator | Participants are injected with an appropriate amount(up to 2.0ml) depending on the degree of nasolabial folds at baseline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DKM-410 | Device | Injection up to 2.0ml |
| |
| Juvederm ULTRA PLUS XC 1.0ml |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | South Korea |
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| Device |
Injection up to 2.0ml |
|
| 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 |