Unique ID issued by UMIN | UMIN000038977 |
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Receipt number | R000044451 |
Scientific Title | Effects of consumption of the test food in healthy Japanese subjects' skin: a randomized, double-blind, placebo-controlled, parallel-group trial |
Date of disclosure of the study information | 2019/12/25 |
Last modified on | 2022/09/13 10:07:04 |
Effects of consumption of the test food in healthy Japanese subjects' skin
Effects of consumption of the test food in healthy Japanese subjects' skin
Effects of consumption of the test food in healthy Japanese subjects' skin: a randomized, double-blind, placebo-controlled, parallel-group trial
Effects of consumption of the test food in healthy Japanese subjects' skin
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on moisture of the skin, viscoelasticity of the skin, and collagen concentration in the skin in healthy Japanese subjects.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured values at four, eight and 12 weeks after consumption and calculate the amount of change of moisture of the skin (cheek and back of the hands)
1. The measured values at four, eight and 12 weeks after consumption and calculate the amount of change of transepidermal water loss, viscoelasticity of the skin, indensity, skin thickness, low echologenic band (LEB) (cheek and back of the hands)
2. The measured value at four, eight and 12 weeks after consumption of original questionnaires
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Food |
Duration: 12 weeks
Test food: Active tablet
Administration: Take two tablets per day after breakfast with water.
* If you forget to take the tablets, take tablets as soon as you remember during the day.
Duration: 12 weeks
Test food: Placebo
Administration: Take two tablets per day after breakfast with water.
* If you forget to take the tablets, take tablets as soon as you remember during the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are anxious about moisture of the skin
3. Subjects who are judged as eligible to participate in the study by the physician
4. Subjects who have relatively low moisture of the skin (cheek) before screening and advance examination
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
5. Subjects who have been diagnosed with atopic dermatitis
6. Subjects who use any other products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, and face masks, skin lotions, milky lotions, and sunscreen, for daily skincare
7. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)
8. Subjects who have got cosmetic surgery
9. Currently taking medicines (include herbal medicines) and supplements
10. Subjects who are allergic to medicines and/or the test food related products
11. Subjects who are pregnant, breast-feeding, and planning to become pregnant
12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
13. Subjects who are judged as ineligible to participate in the study by the physician
52
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@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.
Shinnihonseiyaku Co., Ltd.
Profit organization
Hiroo Dermatology Clinic & Mentors inc.
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
NO
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)
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
2019 | Year | 12 | Month | 25 | Day |
Unpublished
56
Completed
2019 | Year | 12 | Month | 20 | Day |
2019 | Year | 12 | Month | 20 | Day |
2020 | Year | 01 | Month | 06 | Day |
2020 | Year | 05 | Month | 23 | Day |
2019 | Year | 12 | Month | 24 | Day |
2022 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044451
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