NCT05450380

Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic Acid

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mesoestetic Pharma Group S.L. · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Skin Folds
• Wrinkle

Interventions

Type	Name	Description
DEVICE	LIFT001	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.

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-07-31
• Completion: 2024-01-31
• First posted: 2022-07-08
• Last updated: 2024-02-05

Locations

2 sites across 1 country: Spain