The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose (NCT06343610) | Clinical Trial Compass
CompletedNot Applicable
The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose
Slovenia54 participantsStarted 2024-04-15
Plain-language summary
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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion Criteria:
* Caucasian volunteers aged between 21 and 65 years at the time of the signature of Informed consent form (ICF),
* Signed Informed consent form (ICF),
* Fitzpatrick skin phototypes I-III,
* No skin pigmentation disorders,
* In good health condition,
* Willingness to avoid a consumption of any food supplements containing red orange extract, polypodium extract, carotenes or other antioxidants that could interfere with the results during the study,
* Willingness to avoid the sun, tanning beds and tanning products on the test area during the study,
* Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability),
* No changes in dietary habits or dietary supplements in last 2 months prior to inclusion.
* No changes in cosmetic body care routine in last month prior to inclusion on measurement areas.
* No recent participation in any other similar study.
* No sun exposure (both natural and artificial) for at least two months before study start on the test area.
* Absence of sunburn, suntan, scars, or other active dermal lesions on the test area.
* Colour uniformity of the test area (without tattoo, nevi, blemishes or solar lentigo and without hair).
Exclusion Criteria:
* Pregnancy or breastfeeding or planning pregnancy in next 6 months (for women)
* Known or suspected allergy to any ingredient of the tested products or UV radiation.
* Dermatological problems in the test area or the requirement for …