Unique ID issued by UMIN | UMIN000055012 |
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Receipt number | R000062850 |
Scientific Title | Effects of consumption of the test food on skin moisture: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2024/07/18 |
Last modified on | 2024/07/18 18:13:00 |
Effects of consumption of the test food on skin moisture
Effects of consumption of the test food on skin moisture
Effects of consumption of the test food on skin moisture: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on skin moisture
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effect of continuous consumption for eight weeks of the test food on skin moisture.
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of transepidermal water loss (TEWL) at eight weeks after consumption (8w)
1. The amount and rate of change from screening (before consumption; Scr) of TEWL at 8w
2. The measured values of the moisture content of skin surface, epidermal growth factor (EDF), fibroblast growth factor-21 (FGF21), platelet-derived growth factor-BB (PDGF-BB), and image analysis (pigmentation, redness, skin texture, wrinkles, volumes, and facial pores) at 8w, and the amount and rate of changes of them from Scr
3. The measured values of moisture/oil content, facial pores, melanin/stains, wrinkles, porphyrin/sebum prediction, and corneum by a microscope at 8w, and the amount and rate of changes of them from Scr
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Educational,Counseling,Training
Food |
Duration: Eight weeks
Test food: Active food
Duration: Eight weeks
Test food: Placebo food
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men and women
3. Adults
4. Healthy individuals
5. Individuals who are concerned about skin dryness
6. Individuals whose TEWL is relatively high
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines or foods related to the test products
7. Individuals who are engaged in occupations involving outdoor work
8. Individuals who plan to take trips that will expose them to a lot of sunlight, such as swimming in the sea during this study
9. Individuals who have been diagnosed with atopic dermatitis
10. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions such as face masks, milky lotions, and sunscreen for daily skincare
11. Individuals who habitually receive skincare treatment (such as aesthetic treatment) or use instruments for beauty treatment (such as facial treatment device)
12. Individuals who have undergone cosmetic surgery
13. Individuals who are pregnant, lactating, or planning to become pregnant during this study
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician
60
1st name | Tatsuya |
Middle name | |
Last name | Izumi |
Hiroo Dermatology Clinic & Mentors inc.
Director
150-0012
1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
03-5795-1112
dr_izumi@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Toyo Sugar Refining Co., Ltd.
Profit organization
Hiroo Dermatology Clinic & Mentors inc.
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association Minami-machi Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2024 | Year | 07 | Month | 18 | Day |
Unpublished
Open public recruiting
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 07 | Month | 18 | Day |
2025 | Year | 02 | Month | 03 | Day |
2024 | Year | 07 | Month | 18 | Day |
2024 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062850
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