Status:
COMPLETED
The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
Lead Sponsor:
VIST - Faculty of Applied Sciences
Collaborating Sponsors:
European Regional Development Fund
Ministry of Education, Science and Sport, Republic of Slovenia
Conditions:
Minimal Erythema Dose
Skin Viscoelasticity
Eligibility:
FEMALE
25-55 years
Phase:
NA
Brief 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 divi...
Eligibility Criteria
Inclusion
- 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,
- 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.
Exclusion
- 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,
- 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
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03811977
Start Date
March 4 2019
End Date
August 30 2019
Last Update
September 3 2019
Active Locations (1)
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1
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, Slovenia, 1000