NCT04505319

Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit

Prospective, Single Center Study for the Clinical Evaluation of the Safety and Performance of a Dermal Filler in Correction of Mid-face Age-related Volume Deficit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Relife S.r.l. · Industry
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

Detailed description

Prospective, non comparative, single center study, on healthy female subjects. The scope is to evaluate the performance and safety of a dermal filler (definisse core filler plus lidocaine) to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

Conditions

• Aesthetics
• Intradermal Injections

Interventions

Type	Name	Description
DEVICE	DEFINISSE CORE FILLER	DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result). A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face

Timeline

• Start date: 2020-09-14
• Primary completion: 2022-04-08
• Completion: 2022-04-08
• First posted: 2020-08-10
• Last updated: 2022-05-06

Locations

1 site across 1 country: France