Healthy adults
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese male and female aged between 19 and 60 at the time of informed consent 2. Subjects whose Fitzpatrick skin phototype is type II or type III 3. Subjects who can come on the designated inspection day and can be inspected 4. Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarily participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent 5. Subjects who do not meet the exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Subjects with photosensitivity disorder 2. Subjects taking medicine that may affect light sensitivity of the skin 3. Subjects taking anti-inflammatory medicine at least once a month, or who are planning to take them during the study period 4. Subjects who may suffer from seasonal allergy symptoms such as hay fever, and take medicine for them. 5. Subjects who have symptoms of skin diseases on the evaluation site which may affect the test results 6. Subjects who have symptoms of indigestion 7. Subjects with a digestive organ disease or surgical history that affects digestion and absorption 8. Subjects who smoke or have smoked within the last one year prior to the current study 9. Subjects who have excessive drinking habits 10. Subjects who may develop allergies related to the present study 11. Subjects who routinely use medicine, supplements, FOSHU, and/or food which may affect the results or who are planning to take them during the study period 12. Subjects who are undergoing skin related treatment at dermatology 13. Subjects who are undergoing medical treatment or who requires medical or prophylactic treatment at the time of informed consent 14. Subjects who have or had a medical history of serious hepatopathy, kidney damage, heart disease, hematological or blood disease 15. Subjects who is planning to have major lifestyle changes during the study period 16. Subjects who are likely to be exposed to exceeded UV-light for a long time during the study period 17. Shift workers 18. Subjects who have participated in other human studies within the past one month 19. Subjects who have used external preparations, cosmetology, or treatment history that may affect the test results on the measurement sites within the past one month 20. Subjects who are pregnant or lactating, or who intend to become pregnant 21. Subjects who are judged as unsuitable participant by the doctor for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal erythema dose (MED) | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal tanning dose (MTD) Skin color (L*, a*), Melanin index Subgroup analysis based on baseline MED, skin photo type and gender | — |
Countries
Japan
Contacts
Nikoderm Research Inc. Evaluation Division