The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects. The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
12- week dietary supplementation with placebo syrup (0 mg lutein/day)
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.
Time frame: 12 weeks
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.
Time frame: 12 weeks
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
For assessments of skin elasticity viscoelasticity measurements will be performed. Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
Time frame: 12 weeks
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