NCT04970290

Clinical and Instrumental Evaluation on Definisse Threads

Face REshaping Effect With Definisse Threads: Clinical and Instrumental Evaluation ( FREE Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Relife S.r.l. · Industry
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed

Detailed description

The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed to evaluate the modification of skin surface characteristics, the reshaping effect of the face, the subject's satisfaction at each visit, the presence/absence of the threads after the implantation and the global pain perception during the implant procedure..

Conditions

• Face

Interventions

Type	Name	Description
DEVICE	Definisse threads free floating and definisse threads double needle	Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30

Timeline

• Start date: 2021-11-06
• Primary completion: 2023-02-21
• Completion: 2023-06-15
• First posted: 2021-07-21
• Last updated: 2023-06-22

Locations

1 site across 1 country: Italy