The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose

Last updated: February 7, 2025
Sponsor: VIST - Faculty of Applied Sciences
Overall Status: Completed

Phase

N/A

Condition

Skin Wounds

Rash

Hives (Urticaria)

Treatment

Active product

Placebo

Clinical Study ID

NCT06343610
VIST TO-UV 01-2024
  • Ages 21-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Caucasian volunteers aged between 21 and 65 years at the time of the signature ofInformed 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 orangeextract, polypodium extract, carotenes or other antioxidants that could interferewith the results during the study,

  • Willingness to avoid the sun, tanning beds and tanning products on the test areaduring the study,

  • Willingness to follow all study procedures and keeping a diary during the study (tofollow their compliance and palatability),

  • No changes in dietary habits or dietary supplements in last 2 months prior toinclusion.

  • No changes in cosmetic body care routine in last month prior to inclusion onmeasurement areas.

  • No recent participation in any other similar study.

  • No sun exposure (both natural and artificial) for at least two months before studystart 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 lentigoand without hair).

Exclusion

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 annual mole checksby a dermatologist.

  • Pharmacological treatments (both locally or systemically) that could interfere withthe results.

  • Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the bodynot in direct contact with the allergen)

  • Use of self-tanning products for at least 2 months before study start.

  • Medication with photosensitizing potential, drugs, corticoids in last month prior tostudy start.

  • Regular consumption of food supplements containing red orange extract, polypodiumextract, carotenoids or other antioxidants or supplements able to induce skin colourin last month before inclusion into the study.

  • Any clinically significant history of melanoma or skin cancer (including theirimmediate family), serious metabolic disease, digestive tract disease, liverdisease, kidney disease, haematological disease or other illness that couldinterfere with the study.

  • History of severe reactions from exposure to sunlight (i.e., polymorphous lighteruption)

  • Any surgery, chemical or physical treatment on the experimental area within the 12months prior to the study or foreseeing it for the duration of the study.

  • Regular depilation of test area.

  • Planning a hospitalization during the study.

  • Impaired immune system due to autoimmune diseases, or use of immunosuppressivemedication.

  • Mental incapacity that precludes adequate understanding or cooperation.

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Active product
Phase:
Study Start date:
April 15, 2024
Estimated Completion Date:
September 10, 2024

Study Description

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.

Connect with a study center

  • VIST - Faculty of Applied Sciences, Institute of Cosmetics

    Ljubljana, 1000
    Slovenia

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.