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This is a prospective, randomized, controlled clinical investigation designed to evaluate the performance and safety of DMFI300 for the treatment of nasolabial folds. 30 adult participants will receive treatment with the investigational device and the comparator device using a split-face design. 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 |
|---|---|---|---|
| DMFI300 | Experimental | Injection of DMFI300 |
|
| Ellansé-M | Active Comparator | Injection of Ellansé-M |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMFI300 | Device | Injection of DMFI300 for nasolabial folds. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) as Assessed by the Evaluating 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 blinded EI will assess the change from baseline to Month 12 for each nasolabial fold treated with DMFI300 or Ellansé-M. | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Wrinkle Severity Rating Scale (WSRS) Assessed by the Evaluating 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). Changes from baseline will be assessed for each nasolabial fold treated with DMFI300 or Ellansé-M by the EI and TI. | Baseline to Month 1,3,6,9 |
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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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| Ellansé-M |
| Device |
Injection of Ellansé-M for nasolabial folds. |
|
| Global Aesthetic Improvement Scale (GAIS) Assessed by the Treating Investigator (TI) and the Subject | GAIS is a 5-point global improvement scale (3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse). The TI and subject will independently assess GAIS for each nasolabial fold treated with DMFI300 or Ellansé-M. | Month 1,3,6,9,12 |
| Subject Satisfaction With Treatment Using a Five-Point Likert Scale | Subject satisfaction with treatment will be evaluated using a five-point Likert scale for each nasolabial fold treated with DMFI300 or Ellansé-M. | Month 12 |
| Proportion of Subjects Receiving Touch-up Treatment | Proportion of subjects who receive additional touch-up treatment at Month 1 after the initial injection if suboptimal improvement is observed. | Month 1 |
| Incidence of Treatment-Related Adverse Events (TRAEs), Adverse Events (AEs), Serious Adverse Events (SAEs), and Device Deficiencies (DDs) | All TRAEs, AEs, SAEs, and device deficiencies will be recorded and evaluated throughout the clinical investigation. | Baseline through Month 12 |