Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression) activated by UV radiation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
Time frame: Day 84
Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples
Time frame: Day 84
Changes in MMP-1 levels measured in skin samples
Time frame: up to day 84
Changes in MMP-9 levels measured in skin samples
Time frame: up to day 84
Changes in MMP-3 levels measured in skin samples
Time frame: up to day 84
Changes in pro-MMPs levels measured in skin samples
Time frame: up to day 84
Changes in tissue inhibitor (TIMP-1) levels measured in skin samples
Time frame: up to day 84
Heme oxygenase-1 level measured in skin samples
Time frame: up to day 84
Density of Langerhans cells measured in skin samples
Time frame: up to day 84
Cell proliferation and differentiation measured in skin samples
Time frame: up to day 84
Plasma levels of vitamin E
Time frame: up to day 84
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Plasma levels of beta-carotene
Time frame: up to day 84
Number of subjects with adverse events
Time frame: up to 112 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 98
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 84
Assessment of tolerability by volunteer on a 4-point scale
Time frame: Day 84
Recall antigene (skin immune status) measured in the skin sample
Time frame: up to 84 days
Assessment of light sensitivity
Time frame: up to 84 days