Unique ID issued by UMIN | UMIN000048541 |
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Receipt number | R000055304 |
Scientific Title | Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2023/01/19 16:23:01 |
Effects of consumption of the test food on skin condition in healthy Japanese subjects
Effects of consumption of the test food on skin condition in healthy Japanese subjects
Effects of consumption of the test food on skin condition in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on skin condition in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on skin condition in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The moisture of the skin at eight weeks after consumption (8w)
1. The moisture of the skin at four weeks after consumption (4w)
2. Transepidermal water loss, viscoelasticity of the skin (cheek), and an original questionnaire (visual analogue scale) at 4w and 8w
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
3
Treatment
Food |
Duration: Eight weeks
Test food: Fruits oil capsule (high amount)
Administration: Take two capsules with water at any time during the day
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Eight weeks
Test food: Fruits oil capsule (low amount)
Administration: Take two capsules with water at any time during the day
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Eight weeks
Test food: Placebo capsule
Administration: Take two capsules with water at any time during the day
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
20 | years-old | <= |
Not applicable |
Female
1. Japanese
2. Women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects whose moisture of the skin is relatively low
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. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have been diagnosed with atopic dermatitis
5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
6. Subjects who are currently taking medications (including herbal medicines) and supplements
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects 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
9. Subjects who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)
10. Subjects who have undergone cosmetic surgery
11. Subjects who are pregnant, lactation, or planning to become pregnant during this trial
12. Subjects who suffer from COVID-19
13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
14. Subjects who are judged as ineligible to participate in this study by the physician
90
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.
Gifu Shellac Manufacturing Co.,Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Hiroo Dermatology Clinic & Mentors inc.
Nerima Medical Association, Minami-machi 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
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2022 | Year | 08 | Month | 01 | Day |
Unpublished
99
No longer recruiting
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 07 | Month | 20 | Day |
2022 | Year | 08 | Month | 01 | Day |
2022 | Year | 12 | Month | 25 | Day |
2022 | Year | 08 | Month | 01 | Day |
2023 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055304
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