The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride
DERMING
Milan, MI, Italy
Change from baseline of neck skin roughness and laxity clinical grade
Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of superficial skin hydration
Skin electrical capacitance value was measured mono-laterally on the neck with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of deep skin hydration
Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of skin density
A little skin area of about 7 cm2 at level of neck was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of skin plastoelasticity
Superficial and deep skin plastoelasticity was measured mono-laterally on the neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
Time frame: Baseline (T0), 1 month (T1), 4 months (T2)
Change from baseline of photographic documentation
2D pictures of the neck
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Time frame: Baseline (T0), 1 month (T1), 4 months (T2)