Unique ID issued by UMIN | UMIN000043096 |
---|---|
Receipt number | R000049167 |
Scientific Title | Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study- |
Date of disclosure of the study information | 2021/01/24 |
Last modified on | 2021/08/24 11:14:00 |
Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study-
Inhibitory effect of the test food on ultraviolet-induced skin damage.
Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study-
Inhibitory effect of the test food on ultraviolet-induced skin damage.
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
This study examines effects of test food on ultraviolet-induced skin damage.
Efficacy
Confirmatory
Minimal erythema dose (MED)
Minimal tanning dose (MTD)
Skin color (L*, a*), Melanin index
Subgroup analysis based on baseline MED, skin photo type and gender
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Prevention
Food |
Ingestion of test food for 9 weeks
Ingestion of placebo for 9 weeks
20 | years-old | <= |
65 | years-old | > |
Male and Female
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
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
60
1st name | Kei |
Middle name | |
Last name | Yui |
FANCL Corporation
Research Institute, Health science research center
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
045-820-3755
ke-yui@fancl.co.jp
1st name | Yuka |
Middle name | |
Last name | Anno |
Nikoderm Research Inc.
Evaluation Division
541-0052
1-6-14 Azuchimachi,Chuo-ku,Osaka City, OSAKA, Japan
06-6125-3501
anno@nikkolgroup.com
FANCL Corporation
FANCL Corporation
Profit organization
Society of Glycative Stress Research
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
03-6709-8842
info@toukastress.jp
NO
株式会社ニコダームリサーチ(大阪府)
医療法人共創会 AMC西梅田クリニック
2021 | Year | 01 | Month | 24 | Day |
Unpublished
Completed
2020 | Year | 12 | Month | 21 | Day |
2020 | Year | 12 | Month | 29 | Day |
2021 | Year | 01 | Month | 25 | Day |
2021 | Year | 04 | Month | 08 | Day |
2021 | Year | 01 | Month | 22 | Day |
2021 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049167
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