Minimal Erythema DoseVIST LuteinNCT03811977
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
A study testing Lutein syrup in people with Minimal Erythema Dose and Skin Viscoelasticity, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial summary
The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density
- What is being tested?
- Lutein syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 4 Mar 2019to 30 Aug 2019
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian female volunteers aged between 25 and 55 years at the time of the signature of Informed consent form (ICF),
- Signed Informed consent form (ICF),
- Fitzpatrick skin phototypes II and III,
- No skin pigmentation disorders,
- In good health condition,
- Willingness to avoid a consumption of any food supplements containing carotenes or other antioxidants during the study,
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- Willingness to avoid the sun, tanning beds and tanning products on the gluteal area during the study,
- Willingness to follow all study procedures and keeping a diary for during the study (to follow their compliance and palatability),
- No changes in dietary habits or dietary supplements in last month prior to inclusion.
- No changes in cosmetic facial and body care routine in last month prior to inclusion on measurement areas.
Who cannot join
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products or UV radiation,
- Changes in dietary habits and dietary supplementation in last month prior to inclusion,
- Veganism,
- Changes in cosmetic facial and body care routine in last month prior to inclusion.
- Diagnosed and uncontrolled/untreated/unregulated disease,
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- Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease.
- Acute skin diseases,
- Regular consumption of food supplements containing carotenoids or other antioxidants in last month before inclusion into the study.
- Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
- Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
- Gluteal hyperpigmentation,
- Mental incapacity that precludes adequate understanding or cooperation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
Official title: The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study
The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects. The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.
- Conditions
- Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density
- Being tested
- Lutein syrup, Placebo syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein syrupDietary supplement
12- week dietary supplementation with lutein syrup (20 mg lutein/day)
Placebo syrupDietary supplement
12- week dietary supplementation with placebo syrup (0 mg lutein/day)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks. Receives: Dietary Supplement: Lutein syrup |
| Placebo group | Placebo comparator | Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks. Receives: Dietary Supplement: Placebo syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.
Measured: 12 weeks
Secondary outcomes (2)
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.
Measured: 12 weeks
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
For assessments of skin elasticity viscoelasticity measurements will be performed. Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start4 Mar 2019
- Primary completion2 Jul 2019
- Study completion30 Aug 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Higher Education, Science and Technology, Solvenia, Dermatologija Bartenjev Rogl, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, Study director, Head of Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811977
- Sponsor's protocol ID
- VIST F4F Lutein-MED 01-2018
- Acronym
- VIST Lutein
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03811977
- Acronym / sponsor ID
- VIST Lutein / VIST F4F Lutein-MED 01-2018
- Conditions
- Minimal Erythema Dose, Skin Viscoelasticity, Dermis Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Ministry of Higher Education, Science and Technology, Solvenia, Dermatologija Bartenjev Rogl, Slovenian Research Agency, Valens Int. d.o.o., Slovenija
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 22 Jan 2019 (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.
The double-center, randomized, placebo-controlled, one-period effectiveness study will include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III). Subjects will be divided in two groups, 15 in each. One group (test group) will receive investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo group) placebo syrup. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects. The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. The secondary objectives are to assess effects of investigational product on dermis density and skin viscoelasticity after 12 weeks of dietary supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Dietary Supplement: Lutein syrupTest group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo syrupPlacebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Caucasian female volunteers aged between 25 and 55 years at the time of the signature of Informed consent form (ICF),
- Signed Informed consent form (ICF),
- Fitzpatrick skin phototypes II and III,
- No skin pigmentation disorders,
- In good health condition,
Key exclusion criteria (13 listed)
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products or UV radiation,
- Changes in dietary habits and dietary supplementation in last month prior to inclusion,
- Veganism,
- Changes in cosmetic facial and body care routine in last month prior to inclusion.
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 |
|---|---|---|
| Lutein syrup12- week dietary supplementation with lutein syrup (20 mg lutein/day) | Dietary supplement | Test group |
| Placebo syrup12- week dietary supplementation with placebo syrup (0 mg lutein/day) | Dietary supplement | Placebo group |
Primary outcome
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
Time frame: 12 weeks
The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.
2 secondary outcomes
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Time frame: 12 weeks
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
Time frame: 12 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 3 Sep 2019.
- 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.
Katja Žmitek study director
Head of Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein syrup in people with Minimal Erythema Dose and Skin Viscoelasticity, 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 10 inclusion and 13 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 3 Sep 2019. 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?
Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose (time frame: 12 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 3 Sep 2019.