UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024990 |
|---|---|
| Receipt number | R000028704 |
| Scientific Title | Effects of Plant-Derived Products for Skin |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2017/03/12 14:15:16 |
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Basic information
Public title
Effects of Plant-Derived Products for Skin
Acronym
Effects of Plant-Derived Products for Skin
Scientific Title
Effects of Plant-Derived Products for Skin
Scientific Title:Acronym
Effects of Plant-Derived Products for Skin
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines effects of a plant-derived product on female's skin condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Skin moisture content (Week 0, Week 6, Week 12)
Key secondary outcomes
*Secondary outcomes
[1]Transepidermal water loss (Week 0, Week 6, Week 12)
[2]Colour difference (Week 0, Week 6, Week 12)
[3]Observation for skin condition by a specialist (Week 0, Week 6, Week 12)
[4]Anti-Aging QOL Common Questionnaire (Week 0, Week 6, Week 12)
[5]Profile of Mood States Japanese Version (Week 0, Week 6, Week 12)
[6]Visual Analogue Scale (Week 0, Week 6, Week 12)
*Safety
[1]Diagnosis by doctors (Week 0, Week 6, Week 12)
*Other outcomes
[1]Subject's diary(From the first day of ingestion of a test material to the last day of the test)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (8g in a day; 12 weeks)
Interventions/Control_2
Oral intake of the placebo product (8g in a day; 12 weeks)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Females aged 30-59 years
[2]Individuals who are healthy and have no chronic physical disease including skin disease
[3]Individuals who are concerning on dry skin
[4]Individuals whose written informed consent has been obtained
[5]Individuals who can have an examination in a designated day
[6]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[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 have milk allergy
[9]Individuals who are sensitive to test product or other foods, and medical products
[10]Individuals who are or are possibly pregnant, or are lactating
[11]Individuals who have an addiction to alcohol or a mental illness
[12]Individuals who are a smoker
[13]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period
[14]Individuals with probable seasonal allergy, such as pollinosis, during the test period
[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 had been conducted an operation on the test spot
[21]Individuals who participated in other clinical studies in the past 3 months
[22]Individuals judged inappropriate for the study by the principal
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Nakata |
Organization
Medical Corporation Bokushinkai CLINTEXE Clinic
Division name
Director
Zip code
Address
4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL
03-6801-8480
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyasu Tamura |
Organization
TES Holdings Co., Ltd
Division name
Department of Development for Clinical Trials
Zip code
Address
6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL
+81-3-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Yakult Health Foods Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2017 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028704
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| Registered date | File name |
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