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This is a prospective clinical investigation designed to evaluate the performance and safety of DMFI150 for the treatment of nasolabial folds. 30 adult participants will receive a single treatment with the investigational device. The study will assess wrinkle severity using validated aesthetic evaluation scales, as well as overall safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMFI150 | Experimental | Single injection of DMFI150 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMFI150 | Device | Injection of DMFI150 for nasolabial folds. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluator Investigator (EI) | WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. The EI will assess the change from baseline to Month 12. | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluator Investigator (EI) and the Treating Investigator (TI) | WSRS is a validated 5-point ordinal scale used to evaluate wrinkle severity (1 = Absent, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme). Higher scores indicate more severe wrinkles. Changes from baseline will be assessed by both EI and TI. | Baseline to Month 1,3,6,9,12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Clinic | Recruiting | Marbella | Spain |
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| Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and by the Subject | GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse). Higher scores indicate greater improvement. Both the subject and TI will rate GAIS. | Baseline to Month 1,3,6,9,12 |
| Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs) | All TRAEs, AEs, SAEs, and DDs will be recorded and assessed according to the clinical investigation plan. | Baseline through Month 12 |