Purpose/Objectives of the Study: Regenerative medicine, as well as aesthetic plastic surgery and dermatology field persistently seeks innovative, minimally invasive interventions to enhance skin quality and mitigate signs of aging. This study evaluates the regenerative capabilities of a new medical device focused on dermal redensification, induced by injections of single-strand alpha 1 collagen, to verify its ability, in a specific formulation (contained within a matrix of hyaluronic acid and carboxymethylcellulose), to induce dermal stimulation in both scar outcomes and regenerative medicine applied to skin aging.
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"Change from Baseline to day 15 in the mean depth of skin wrinkles (mm)
Timeframe: baseline and day 15
"Change from Baseline to day 30 in the mean depth of skin wrinkles (mm)
Timeframe: baseline and day 30
"Change from Baseline to day 60 in the mean depth of skin wrinkles (mm)
Timeframe: baseline and day 60
"Change from Baseline to day 15 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Timeframe: baseline and day 15
"Change from Baseline to day 30 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Timeframe: baseline and day 30
"Change from Baseline to day 60 in melanin quantity ( arbitrary unit from 0.1-1 indicated by Antera 3D scanner)
Timeframe: baseline and day 60
"Change from Baseline to day 15 in hemoglobin quantity.
Timeframe: baseline and day 15
"Change from Baseline to day 30 in hemoglobin quantity.
Timeframe: baseline and day 30
"Change from Baseline to day 60 in hemoglobin quantity.
Timeframe: baseline and day 60
"Change from Baseline in the Mean values of FACE-Q questionnaire at 15 days"
Timeframe: baseline and day 15
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 30 days"
Timeframe: baseline and day 30
"Change from Baseline in the Mean values of FACE-Q questionnaire, at 60 days"
Timeframe: baseline and day 60
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 15 days"
Timeframe: baseline and day 15
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 30 days"
Timeframe: baseline and day 30
"Change from Baseline in the Mean values of GAIS Global Aesthetic Improvment Scale, at 60 days"
Timeframe: baseline and day 60