None (Healthy adults)
Conditions
Interventions
Intake period: 5 weeks Test food: Soft capsule containing paprika carotenoid extract (100 mg) Once a day (1 capsule/day)
Sponsors
RIKEN VITAMIN CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. healthy adult males and females between the ages of 30 and 60 years at the time of consent 2. have a Fitzpatrick skin phototype of type II or III 3. Participants whose dorsal skin can be determined to have UV erythema. 4. Participants who were judged to have MED in the second, third, or fourth of the six levels of UV radiation at the time of MED judgment before ingestion of the test product (Day 1). 5. Participants who be able to visit the test site on all test days 6. Those who can provide written consent to participate in the study voluntarily
Exclusion criteria
Exclusion criteria: 1. smoker 2. patients with a history of atopic dermatitis or a predisposition to atopy 3. those who have factors on the skin of the evaluation site that may affect the results of the test 4. those who have been diagnosed as photosensitive 5. those who have undergone or will undergo cosmetic procedures on the evaluation site 6. those who have undergone any special skin care treatment within the past 4 weeks, or plan to do so during the examination period 7. participants who have continuously used skin care products or health foods that advocate or emphasize efficacy similar to or related to the efficacy to be studied in this study 8. those who have changed or newly started using health food products or basic cosmetics or sunscreen products within the past four weeks 9. those who have been or will be exposed to ultraviolet radiation beyond their daily activities within the past 4 weeks 10. those who may be allergic to food 11. those who have been taking medicines which are indicated for the treatment of freckles, pigmentation due to sunburn, and melasma 12. those who work night shifts or day/night shifts 13. those who are undergoing medical treatment for the treatment or prevention of disease at the time of obtaining consent, or those who are judged to be in need of treatment 14. those who are taking drugs that affect the photosensitivity of the skin 15. those who continuously use or take anti-inflammatory drugs at least once a month 16. participants who had a history of serious diseases. 17. undergoing hormone replacement therapy for menopause or postmenopausal women, or those who have not been under treatment for at least 6 months 18. those with a history of alcohol or drug dependence. 19. pregnant or lactating at the time of consent, or who wish to become pregnant during the study period 20. those who have participated in other human studies within the past 4 weeks 21. those who are judged as unsuitable to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal erythema dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin condition [transepidermal water loss, stratum corneum water content, skin color(L*, a*, b*), roughness (Ra) analysis by ntera3D, photography of irradiated area] Quantification of IL-1alpha and IL-1RA using tape strips | — |
Countries
Japan
Contacts
Public ContactNaofumi UMIGAI
RIKEN VITAMIN CO., LTD. Healthcare unit
Outcome results
None listed