This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters.
This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters. The study will be performed on 54 adults, between the ages 21 and 65 years and will include daily dietary supplementation over 8-weeks period. Participants will be randomly assigned in one of two groups, 27 in each. One group (test group) will receive investigational product, a syrup containing red orange extract, Calaguala extract and vitamins A, C, D, E and the other placebo syrup. Participants will continuously receive placebo or investigational product for 8 weeks in order to determine multiple-dose effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
54
Contains a complex of: Calaguala leaves extract (Polypodium leucotomos), vitamin C (L-ascorbic acid), blood orange fruit extract (Citrus sinensis; red orange extract), vitamin E (alpha-tocopheryl acetate), vitamin A (retinyl palmitate), vitamin D3 cholecalciferol.
No active ingredients.
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia
Change of minimal erythema dose
Increase of minimal erythema dose (MED) from baseline in test group in comparison to placebo group. Irradiation for determination of MED (J/cm2), will be performed with automated erythema tester Dermalight® 80 MED Tester (Dr Hoenle Medizintechnik GmbH, Germany; UVB 311 nm).
Time frame: 8 weeks
Change of redness formation
Decrease of redness formation following UVB irradiation in test group in comparison to placebo group. Redness measurements (CIE a\*) will be done before irradiation and after 24 hours post irradiation and variation of a\* calculated for each of the follow-up visits before and after 8 weeks of supplementation. The skin colour will be measured by Cortex Colorimeter DSM-4 (Cortex Technology ApS, Denmark). The colorimeter uses CIE L\* a\* b\* tridimensional colour space; a\* values (red-green axis) are an indicator of erythema/redness formation.
Time frame: 8 weeks
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