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

Relife S.r.l.1 site in 1 country50 target enrollmentSeptember 14, 2020

ConditionsAesthetics Intradermal Injections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aesthetics
Sponsor: Relife S.r.l.
Enrollment: 50
Locations: 1
Primary Endpoint: Global aesthetic improvement one month
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 14, 2020

End Date

April 8, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Relife S.r.l.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subject;
•Sex: female;
•Age: between 40 and 60 years;
•BMI between 18 and 25 included.
•Subject having given freely and expressly his informed consent;
•Subject with a volume deficit on malar area and requiring a correction using a filler;
•Subject, psychologically able to understand the study related information and to give a written informed consent;
•Subject affiliated to a health social security system;
•Female of childbearing potential using a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study (oral contraceptives, patch contraceptives, injection contraceptives, male condom with intra-vaginal spermicide, diaphragm or cervical cap with spermicide, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral tubal ligation), vasectomized partner, or sexual abstinence).
•Female subjects of childbearing potential must have a negative pregnancy test at the inclusion;

Exclusion Criteria

•Pregnant or nursing woman or planning a pregnancy during the study.
•Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
•Subject in a social or sanitary establishment.
•Subject participating to another research on human beings or being in an exclusion period for a previous study.
•Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
•Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
•Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied zones which may interfere with the study at the investigator appreciation.
•Subject with unstable weight or planning to do a dietary regime during the study.
•Subject with too severe mid-face volume deficit.
•Subjects without teeth or with dental prostheses

Outcomes

Primary Outcomes

Global aesthetic improvement one month

Time Frame: one month after injection (first visit from Day 0)

Clinical evaluation of the global aesthetic improvement (GAIS) one month after injection of the investigational medical device in subjects with mid-face age-related volume deficit.

Secondary Outcomes

Clinical evaluation on restoration and/or augmentation of facial volume(from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months)
subject satisfaction on Aesthetic improvement(at each time point after injection, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months.)
Evaluation of injector satisfaction on using medical device(During the injection Day 0 and 1 one month after the first injection (Month 1))
evaluation on skin quality after injection with Dermascan(from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection)
evaluation on skin thickness after injection with Dermascan(from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection)
evaluation onskin biomechanical properties after injection with Cutometer(from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection)
Need of a touch-up injection(after one month of injection (Month 1))
Objective evaluation on restoration and/or augmentation of facial volume(from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months)
Global aesthetic improvement during follow up(3, 6, 9, 12 and 18 months after injection)
Evaluation of product safety(1 month after each injection for ISRs and 21 months for adverse event collection)