Study to validate the safety and efficacy of the Hyaluronic Acid +Collagen filler 40 patients will undergo through 3 visits one to asses the health and apply the filler one after 4 weeks to check the results one after 16 weeks for the final check and results validation Safety assessed with analysis of the Adverse Events
The patients chosen with facial laxity characteristics, at the first visit will be assessed and will receive the treatment (microinjections) in the cheekbone area, over the lips and in the marionette lines. After 4 weeks the first visit will assess the change of the tissutal structure with non invasive measurements.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intradermal injection
Ospedale Tor Vergata
Roma, Italy
RECRUITINGSafety: no adverse events
test the safety of the device evaluating any potential adverse event
Time frame: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using GAIS (Global Aesthetic Improvement Scale) scale
Time frame: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface using Facial Volume Loss Scale (FVLS)
Time frame: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface evaluating the face volume
Time frame: 16 weeks
Efficacy: change of wrinkles and scars
test the efficacy of the device measuring the skin surface with skin hydratation measurement
Time frame: 16 weeks
Duration of the efficacy
measure the duration of the treatment
Time frame: 16 weeks
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