An interventional study of Active product and Placebo in Minimal Erythema Dose, sponsored by VIST - Faculty of Applied Sciences. Completed at 1 site in Slovenia. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by VIST - Faculty of Applied Sciences · Not applicable, Interventional, and Prevention
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.
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.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →VIST - Faculty of Applied Sciences is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Active product
Dietary Supplement: Placebo
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.
No active ingredients.
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).
Time frame: 8 weeks
Change of redness formation
Decrease of redness formation following UVB irradiation in test group in comparison to placebo group. Redness measurements (CIE a\*) will be done before irradiation and after 24 hours post irradiation and variation of a\* calculated for each of the follow-up visits before and after 8 weeks of supplementation. The skin colour will be measured by Cortex Colorimeter DSM-4 (Cortex Technology ApS, Denmark). The colorimeter uses CIE L\* a\* b\* tridimensional colour space; a\* values (red-green axis) are an indicator of erythema/redness formation.
Time frame: 8 weeks
Change of melanin index
Change of melanin index (MI) following UVB irradiation in test group in comparison to placebo group. MI measurements will be done before irradiation and after 48 hours post irradiation and variation of MI calculated for each of the follow-up visits before and after 8 weeks of supplementation. MI will be measured by Cortex Colorimeter DSM-4 (Cortex Technology ApS, Denmark). The colorimeter uses CIE L\* a\* b\* tridimensional colour space. MI is a measure of pigmentation of the skin.
Time frame: 8 weeks
Plan to share: No
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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VIST - Faculty of Applied Sciences