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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016504
Receipt No. R000019160
Scientific Title A Study for the Effect of Food Containing Ceramide on Skin Quality
Date of disclosure of the study information 2015/02/20
Last modified on 2016/05/10

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Basic information
Public title A Study for the Effect of Food Containing Ceramide on Skin Quality
Acronym A Study for the Effect of Food Containing Ceramide on Skin Quality
Scientific Title A Study for the Effect of Food Containing Ceramide on Skin Quality
Scientific Title:Acronym A Study for the Effect of Food Containing Ceramide on Skin Quality
Region
Japan

Condition
Condition Effect of Food Containing Ceramide on Skin Quality
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate efficacy of food containing ceramide on skin quality by Japanese adult males and fmmales (aged 20-60 years).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Color-difference
Transepidermal water loss
Skin moisture content
Skin texture
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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
Other
Interventions/Control_1 Oral ingestion of the test product (12 weeks)
Interventions/Control_2 Oral ingestion of the control product (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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria [1]Japanese males and females aged 20-60 years
[2]Individuals who are healthy and do not treat any disease
[3]Individuals who are aware of skin dullness or dryness
[4]Individuals who sign the consent document after explanation of this study
Key exclusion criteria [1]Individuals using medical products
[2]Individuals with skin disease, such as atopic dermatitis, or strange skin conditions disease at measurement points
[3]Individuals who are sensitive to test products
[4]Individuals with probable seasonal allergy, such as pollinosis, during the test period
[5]Individuals who used cosmetics corresponding to quasi-drug or having whitning or moisturizing effect in the past 1 month or will ingest those foods during the test period
[6]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments claiming whitning effect in the past 1 month or will ingest those foods during the test period
[7]Individuals who will get sunburned during the test period
[8]Individuals who conducted actions, such as hormone replacement therapy, beauty treatment or cosmetic medicine, or diseasae treatment requiring hospital admission, to affect measurement points in the past 3 months
[9]Individuals who are alcohol dependent or have other mental disabilities
[10]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period
[11]Individuals who participated in other clinical studies in the past three months
[12]Individuals who are or are posslibly, or are lactating
[13]Individuals judged inappropriate for the study by the principal
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Nakata
Organization Medical Corporation Bokushinkai CLINTEXE Clinic
Division name Internal Department
Zip code
Address 4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL 03-5405-1059
Email 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 Clinical Trial
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, Japan
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Maruzen Pharmaceuticals 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
Email

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
2015 Year 02 Month 20 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
2015 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 21 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
2015 Year 02 Month 10 Day
Last modified on
2016 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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