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

NCT06343610 | Completed DMC

• 1 other identifier: VIST TO-UV 01-2024
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Minimal Erythema Dose

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Secondary Outcomes (1)

• Change of redness formation

  8 weeks

Other Outcomes (1)

• Change of melanin index

  8 weeks

Study Arms (2)

Test group

ACTIVE COMPARATOR

Dietary Supplement: Active product

Placebo group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Active product DIETARY_SUPPLEMENT

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.

Test group

Placebo DIETARY_SUPPLEMENT

No active ingredients.

Placebo group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).

You may not qualify if:

• 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 checks by a dermatologist.
• Pharmacological treatments (both locally or systemically) that could interfere with the results.
• Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not 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 to study start.
• Any clinically significant history of melanoma or skin cancer (including their immediate family), serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease or other illness that could interfere with the study.
• History of severe reactions from exposure to sunlight (i.e., polymorphous light eruption)
• Any surgery, chemical or physical treatment on the experimental area within the 12 months 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 immunosuppressive medication.
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead

Study Sites (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: April 15, 2024
• Primary Completion: June 14, 2024
• Study Completion: September 10, 2024
• Last Updated: February 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)