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The objective of this clinical investigation is to assess the safety and performance of dermal filler of hyaluronic acid to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections in the lower two thirds of the face at 2 months post-treatment.
The primary endpoint is to assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment. Furthermore, the performance of the device will also be assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS), Wrinkle Severity Rating Scale (WSRS), and 2D images of subjects' faces at 2 months post-treatment.The secondary endpoints are the following:
Secondary Safety Endpoint
Secondary Performance Endpoint
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: LIFT001 | Experimental | LIFT001 is composed by sodium hyaluronate at concentration of 2,5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity. The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFT001 | Device | The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. The dermal filler of hyaluronic acid LIFT001 is applied to the facial area to provide firmness and counteract sagging for the correction of deep wrinkles and imperfections of face. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 2 months time | The primary endpoint is to assess the safety of product LIFT001 by occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 2 months post-treatment. | 2 MONTHS |
| Performance of device LIFT001 at 2 months time - GAIS scale | The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by:
Score Grade Description 7 Very Much Improved Very marked improvement in appearance to 1 Very Much Worse The appearance is very much worse than the original condition | 2 MONTHS |
| Performance of device LIFT001 at 2 months time - WSRS scale | The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: - Wrinkle Severity Rating Scale (WSRS) Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle | 2 MONTHS |
| Performance of device LIFT001 at 2 months time - 2D images | The performance of the device LIFT001 will also be assessed as the aesthetical outcome measured by: - 2D images of subjects' faces at 2 months post-treatment. | 2 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 6, 9 and 12 months time |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dermatologico Internacional - Cdi | Madrid | CAM | 28001 | Spain | ||
| Hospital Ruber Internacional |
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| 12 MONTHS |
| Performance of device LIFT001 at 12 months time - GAIS scale | To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by: - Global Aesthetic Improvement Scale (GAIS) Score Grade Description 7 Very Much Improved Very marked improvement in appearance to 1 Very Much Worse The appearance is very much worse than the original condition | 12 months |
| Performance of device LIFT001 at 12 months time - WSRS scale | To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by: - Wrinkle Severity Rating Scale (WSRS) Score Severity descriptions 4 Extreme Very deep wrinkle, redundant fold (overlapping skin) 0 None No wrinkle | 12 months |
| Performance of device LIFT001 at 12 months time - 2D images | To evaluate the performance of LIFT001 at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by: - 2D images of subjects' faces at 6, 9 and 12 months post-treatment. | 12 months |
| Madrid |
| CAM |
| 28034 |
| Spain |