Clinical trial NCT03811977: The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimal Erythema Dose
Skin Viscoelasticity
Dermis Density
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Ministry of Education, Science and Sport, Republic of Slovenia
name: Dermatologija Bartenjev Rogl
name: Slovenian Research Agency
name: Valens Int. d.o.o., Slovenija
First posted: 2019-01-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
timeFrame: 12 weeks
Secondary outcomes:
measure: Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
timeFrame: 12 weeks
measure: Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Higher School of Applied Sciences, Institute of Cosmetics
Study officials:
affiliation: Head of Research Group
name: Katja Žmitek
role: STUDY_DIRECTOR
References: