Efficacy and tolerance evaluation of an intradermal injective HA and aminoacids based treatment for the area around the eyes
Primary end point of this study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance on the area around the eyes of the"SUNEKOS® 200" injective treatment. Precisely three micro-injection sessions with an interval of 15 days were performed by a specialized dermatologist using periosteal and subepidermal injection techniques, on the area around the eyes of female volunteers with dark circles. An additional aim of this study is to evaluate the product tolerance by both the investigator and volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
The intradermal injection procedure was performed bilaterally, on the area around the eyes including the eyelids, using periosteal and subepidermal injection techniques. This injective procedure consists of micro-wheals of 0.2 ml just above the periosteum and micro-wheals of 0.1 ml very superficially, just under epidermis.
DERMING
Milan, MI, Italy
Change from baseline of wrinkles grade around the eyes
Visual score of crow's feet, according to a reference photographic scale from 0 (no wrinkles) to 7 (very marked wrinkles)
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
Change from baseline of dark circles grade
Visual score of dark circles grade, according to a reference photographic scale from 0 (absent) to 4 (very marked)
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
Change from baseline of roughness profilometric parameters
Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
Change from baseline of dark circles colorimetric parameters
Dark circles colorimetric measured by Chroma Meter CR-200® . L\* represent the lightness of the colour, a\* represent the red component of the colour, b\* represent the dark component of the colour
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
Change from baseline of spectrophotometrical value
Dark circles spectrophotometrical color value measured by a visible-UV-IR spectrophotometer
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)
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change from of photographic documentation
Photographic documentation of the area around the eyes
Time frame: T0 (baseline), T3i+1 (1 day after the 3rd injection treatment with Sunekos 200), T2M (after 2 months), T3M (after 3 months)