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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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
Eurofins Laboratoire Dermscan
Villeurbanne, France
Global aesthetic improvement one month
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.
Time frame: one month after injection (first visit from Day 0)
Global aesthetic improvement during follow up
Clinical evaluation of the global aesthetic improvement (GAIS) 3, 6, 9, 12 and 18 months after injection of the investigational medical device in subjects with mid-face age-related volume deficit.
Time frame: 3, 6, 9, 12 and 18 months after injection
Clinical evaluation on restoration and/or augmentation of facial volume
Clinical evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with a clinical scale (FVLS) Face Volume Loss Scale, with a score from Grade 1 to Grade 5, when Grade 1 is the better outcome .
Time frame: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months
Need of a touch-up injection
evaluation if a touch up injection is needed after one month
Time frame: after one month of injection (Month 1)
Objective evaluation on restoration and/or augmentation of facial volume
Objective evaluation of the investigational medical device effect on the restoration and/or augmentation of facial volume, with cheekbone volume variation evaluation by 3D LifeViz® system
Time frame: from baseline (Day 0) to 1, 3, 6, 9, 12 and 18 months
subject satisfaction on Aesthetic improvement
Evaluation of subject satisfaction using a subjective evaluation questionnaire, (GAIS) Global Aesthetic improvement Scale, the scores is from 1 to 5, when 1 is the better outcome.
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Time frame: 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
Evaluation of injector satisfaction using a subjective evaluation questionnaire
Time frame: During the injection Day 0 and 1 one month after the first injection (Month 1)
evaluation on skin quality after injection with Dermascan
Objective evaluation of the investigational medical device effect on skin quality using Dermascan instrument
Time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
evaluation on skin thickness after injection with Dermascan
Objective evaluation of the investigational medical device effect on skin thickness using Dermascan instrument
Time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
evaluation onskin biomechanical properties after injection with Cutometer
Objective evaluation of the investigational medical device effect on skin biomechanical properties measurements using Cutometer
Time frame: from baseline (Day 0) to 3, 6, 9, 12 and 18 months after initial injection
Evaluation of product safety
Clinical evaluation of the investigational medical device safety with Injection Site Reactions (ISRs) and adverse event collection
Time frame: 1 month after each injection for ISRs and 21 months for adverse event collection