UMIN ID: UMIN000034004
Registered date:03/09/2018
Whitening effect of the supplement and cosmetics when used alone compared to simultaneously
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Healthy person |
Date of first enrollment | 2018/09/04 |
Target sample size | 60 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Test food (Intake priod:12 weeks) Test cosmetics (use priod:12 weeks) Test food and Test cosmetics (use priod:12 weeks) |
Outcome(s)
Primary Outcome | Skin color quantification by spectrophotometer Skin color evaluation by skin color scale |
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Secondary Outcome | VISIA image analysis Questionnaire |
Key inclusion & exclusion criteria
Age minimum | 35years-old |
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Age maximum | 55years-old |
Gender | Female |
Include criteria | |
Exclude criteria | 1)Subjects who have certain diseases and undergoing drug treatment on medication. 2)Subjects who are currently using medication. 3)Subjects who have taken medicines for the purpose of treating diseases within the past one month. 4)Subjects who are suffering or suffered from serious disease. 5)Subject who have skin disease. 6)Subjects who have sensitive skin. 7)Subjects who have severe skin disorders on the face. 8)Subjects who have mole, acne vulgaris, erythema, capillary dilation at the measurement points. 9)Subjects who have may show allergic symptoms to cosmetics. 10)Subjects who may show severe allergic symptoms to the test foods. 11)Subjects who have alcoholism or other psychiatric disorders. 12)Subjects who have smoking habit. 13)Subjects who may change lifestyle habits during the test period. 14)Subjects who are unable to refrain from direct sunlight, during the test period. 15)Subjects who develop pollinosis and may use medication during the study period. 16)Subjects who used or will use of medications, health foods, supplements, which have skin whitening and skin improvement effects during the test period, or who have used any of the above within the past 3 months. 17)Subjects who used cosmetics or medication that may advocate the whitening effect within the past 3 months or who are planning to use them during the test period. 18)Subjects who had treatment history at the evaluation site within the past 6 months. 19)Subjects who are pregnant or breast-feeding. 20)Subjects who are participating in other clinical studies or who have participated in other clinical studies within the past 3 months. 21)Subjects who or whose family work for a company that develops, manufactures or sells health foods, and cosmetics. 22)Subjects who are judged as unsuitable participant for the study by the doctor and the investigator in charge for other reasons. |
Related Information
Primary Sponsor | FANCL Corporation |
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Secondary Sponsor | |
Source(s) of Monetary Support | FANCL Corporation |
Secondary ID(s) |
Contact
public contact | |
Name | Ryoma Shimizu |
Address | 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN |
Telephone | +81-3-6801-8480 |
r.shimizu@tes-h.co.jp | |
Affiliation | TES Holdings Co., Ltd Administrative Department of Clinical Trials |
scientific contact | |
Name | Kei Yui |
Address | 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa Japan |
Telephone | 045-820-3755 |
ke-yui@fancl.co.jp | |
Affiliation | FANCL Corporation Research Institute, Health science research center |