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| Name | Class |
|---|---|
| European Regional Development Fund | OTHER |
| Ministry of Higher Education, Science and Technology, Solvenia | OTHER_GOV |
| Dermatologija Bartenjev Rogl | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks. |
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| Placebo group | Placebo Comparator | Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutein syrup | Dietary Supplement | 12- week dietary supplementation with lutein syrup (20 mg lutein/day) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Žmitek | Head of Research Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Higher School of Applied Sciences, Institute of Cosmetics | Ljubljana | 1000 | Slovenia |
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| Slovenian Research Agency |
| OTHER |
| Valens Int. d.o.o., Slovenija | INDUSTRY |
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| Placebo syrup | Dietary Supplement | 12- week dietary supplementation with placebo syrup (0 mg lutein/day) |
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| 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. | 12 weeks |