Minimal Erythema DoseVIST-TO-UVNCT06343610
The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose
A study testing Active product in people with Minimal Erythema Dose, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Minimal Erythema Dose
- What is being tested?
- Active product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Apr 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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).
Who cannot join
- 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.
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- Medication with photosensitizing potential, drugs, corticoids in last month prior to study start.
- Regular consumption of food supplements containing red orange extract, polypodium extract, carotenoids or other antioxidants or supplements able to induce skin colour in last month before inclusion into the study.
- 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.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
VIST - Faculty of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
Official title: The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose: Randomised Double Blind, Placebo-controlled Study
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.
Read the detailed 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.
- Conditions
- Minimal Erythema Dose
- Being tested
- Active product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active productDietary 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.
PlaceboDietary supplement
No active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | Not described Receives: Dietary Supplement: Active product |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Apr 2024
- Primary completion14 Jun 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Erythema DoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343610
- Sponsor's protocol ID
- VIST TO-UV 01-2024
- Acronym
- VIST-TO-UV
- Status last verified
- Dec 2024
- First submitted
- 26 Mar 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose: Randomised Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06343610
- Acronym / sponsor ID
- VIST-TO-UV / VIST TO-UV 01-2024
- Conditions
- Minimal Erythema Dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Dietary Supplement: Active product |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active productContains 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. | Dietary supplement | Test group |
| PlaceboNo active ingredients. | Dietary supplement | Placebo group |
Primary outcome
Change of minimal erythema dose
Time frame: 8 weeks
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).
1 secondary outcome
Change of redness formation
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active product in people with Minimal Erythema Dose, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of minimal erythema dose (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.