Unique ID issued by UMIN | UMIN000024845 |
---|---|
Receipt number | R000028531 |
Scientific Title | Effects of the Test Food (HB-h009) on Female's Skin Condition |
Date of disclosure of the study information | 2016/11/17 |
Last modified on | 2017/03/12 14:20:33 |
Effects of the Test Food (HB-h009) on Female's Skin Condition
Effects of the Test Food on Female's Skin Condition
Effects of the Test Food (HB-h009) on Female's Skin Condition
Effects of the Test Food on Female's Skin Condition
Japan |
N/A(healthy adults)
Adult |
Others
NO
This study examines effects of the test food (HB-h009) on female's skin condition.
Safety,Efficacy
[1]Colour difference (Week 0, Week 4, Week8)
*Secondary outcomes
[1]Blood flow measurement with laser doppler (Week 0, Week 4, Week 8)
[2]Observation for skin condition by a specialist (Week 0, Week 4, Week 8)
*Safety
[1]Diagnosis by doctors (Week 0, Week 4, Week 8)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)
*Other outcome
Peeling of horny cell layer (Week 0, Week 4, Week 8)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Oral intake of the test product (1 pill in a day; 8 weeks)
Oral intake of the placebo product (1 pill in a day; 8 weeks)
30 | years-old | <= |
55 | years-old | > |
Female
[1]Females aged 35-49 years
[2]Individuals who are healthy and have no chronic physical disease including skin disease
[3]Individuals who are concerning on her dull skin
[4]Individuals who are concerning on her blood circulation of the limbs
[5]Individuals whose menstrual cycle is normal or health condition is stable after menopause
[6]Individuals whose written informed consent has been obtained
[7]Individuals who can have an examination in a designated day
[8]Individuals judged appropriate for the study by the principal
[1]Individuals using medical products
[2]Individuals with skin disease, such as atopic dermatitis
[3]Individuals with strange skin conditions at measurement points
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease
[6]Individuals who contract or have a history of serious gastrointestinal disease
[7]Individuals with serious anemia
[8]Individuals who are sensitive to test product or other foods, and medical products
[9]Individuals who are or are possibly pregnant, or are lactating
[10]Individuals who have an addiction to alcohol or a mental illness
[11]Individuals who are a smoker
[14]Individuals whose bowel habit is irregular
[15]Individuals who are busy to their own work, housework or child care and neglect skin care
[16]Individuals who cannot avoid daylight exposure during the test period
[17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period
[18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months
[19]Individuals who had been conducted an operation on the test spot
[20]Individuals who participated in other clinical studies in the past 3 months
[21]Individuals judged inappropriate for the study by the principal
50
1st name | |
Middle name | |
Last name | Shuji Nakata |
Medical Corporation Bokushinkai CLINTEXE Clinic
Director
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
03-6801-8480
info@tes-h.co.jp
1st name | |
Middle name | |
Last name | Toshiyasu Tamura |
TES Holdings Co., Ltd
Department of Development for Clinical Trials
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
03-6801-8480
info@tes-h.co.jp
TES Holdings Co., Ltd
Hayashibara Co., Ltd.
Profit organization
NO
2016 | Year | 11 | Month | 17 | Day |
Unpublished
Completed
2016 | Year | 10 | Month | 24 | Day |
2016 | Year | 11 | Month | 17 | Day |
2016 | Year | 11 | Month | 15 | Day |
2017 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028531
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |