Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000, Slovenia
NCT Number: NCT03811977
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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Notify Me25 year–55 year
Female
Interventional
Not applicable
Ljubljana, 1000, Slovenia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
12- week dietary supplementation with placebo syrup (0 mg lutein/day)
Time frame: 12 weeks
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
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
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.
VIST - Faculty of Applied Sciences
Other
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study
Acronym: VIST Lutein
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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