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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039072
Receipt No. R000044479
Scientific Title Study for the Effects of a Test Food on Skin Function.
Date of disclosure of the study information 2020/01/10
Last modified on 2020/01/07

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Basic information
Public title Study for the Effects of a Test Food on Skin Function.
Acronym Study for the Effects of a Test Food on Skin Function.
Scientific Title Study for the Effects of a Test Food on Skin Function.
Scientific Title:Acronym Study for the Effects of a Test Food on Skin Function.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines effects of a test food on skin function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Transepidermal water loss (Screening, Week 0, Week 6, Week 12).
Key secondary outcomes *Secondary indexes
[1]Skin moisture content (Screening, Week 0, Week 6, Week 12).
[2]Skin viscoelasticity (Screening, Week 0, Week 6, Week 12).
[3]Collagen Score (Screening, Week 0, Week 6, Week 12).
[4]Observation for skin condition by dermatologists (Screening, Week 0, Week 6, Week 12).
[5]Visual Analogue Scale (Week 0, Week 6, Week 12).

*Safety
[1]Doctor's questions (Screening, Week 0, Week 6, Week 12).
[2]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 food (1 capsule in a day; 12 weeks).
Interventions/Control_2 Oral intake of the placebo food (1 capsule 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]Healthy Japanese females aged 30-59 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disease.
[3]Individuals who are aware of skin dryness.
[4]Individuals whose written informed consent has been obtained after explanation of this study.
[5]Individuals who can have an examination on a designated check 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 a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[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 whose BMI is over 30 kg/m2.
[9]Individuals who are sensitive to test product or other foods, and medical products.
[10]Individuals who had a habit to ingest health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
[11]Individuals who have a habit to ingest health-promoting foods, or supplements containing similar composition with a test food in the past 3 months or will ingest those foods during the test period.
[12]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[13]Individuals who are or are possibly pregnant, or are lactating.
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[15]Individuals who are patient or have a history of psychiatric disease.
[16]Individuals who are a smoker.
[17]Individuals with possible changes of life style during the test period.
[18]Individuals who will develop seasonal allergy symptoms like hay fever and use a drug.
[19]individuals who neglect skin care.
[20]Individuals who will get sunburned during the test period.
[21]Individuals who had been conducted an operation or beauty treatment on the test spot.
[22]Individuals who participated in other clinical studies in the past 3 months.
[23]Individuals judged inappropriate for the study by the principal.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6240-1162
Email info@ueno-asagao.clinc

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@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 Ueno-Asagao Clinic Ethical Review Committee
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel +81-3-6240-1162
Email jimukyoku@tes-h.co.jp

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
2020 Year 01 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 09 Day
Date of IRB
2019 Year 12 Month 11 Day
Anticipated trial start date
2020 Year 01 Month 25 Day
Last follow-up date
2020 Year 04 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 07 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044479

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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