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 * To assess the safety of dermal filler of hyaluronic acid by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment. * To assess the safety of dermal filler of hyaluronic acid by occurrence of all AEs through 2-, 6-, 9-, and 12-months post-treatment. Secondary Performance Endpoint * To evaluate the performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment, assessed as the aesthetical outcome measured by the Global Aesthetic Improvement Scale (GAIS) * Assessment of dermal filler of hyaluronic acid performance of mesofiller® Lift at 6-, 9- and 12-months post-treatment using the Wrinkle Severity Rating Scale (WSRS) * Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acid at 6-, 9- and 12-months post-treatment using 2D images of subjects' faces * Assessment of dermal filler of hyaluronic acid performance of dermal filler of hyaluronic acidt at 6-, 9- and 12-months post-treatment through satisfaction surveys related to the subject's appearance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Centro Dermatologico Internacional - Cdi
Madrid, CAM, Spain
Hospital Ruber Internacional
Madrid, CAM, Spain
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.
Time frame: 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: * 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
Time frame: 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
Time frame: 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.
Time frame: 2 MONTHS
Evaluation of occurrence of Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) of device LIFT001 at 6, 9 and 12 months time
* To assess the safety of LIFT001 by occurrence of Treatment-related Adverse Events (TRAEs) and Serious Adverse Events (SAEs) through 6-, 9-, and 12-months post-treatment. * To assess the safety of LIFT001 by occurrence of all AEs through 2- , 6-, 9-, and 12-months post-treatment.
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Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 months