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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026030
Receipt No. R000029915
Scientific Title Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Date of disclosure of the study information 2017/02/20
Last modified on 2017/12/14

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Basic information
Public title Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Acronym Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Scientific Title Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Scientific Title:Acronym Effects of a Test Food for Improvement of Skin Moisturizing Function and Its Safety
Region
Japan

Condition
Condition N/A(healthy adaults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effects of a test food for improvement of skin moisturizing function and its safety for subjects by 8-week ingestion.
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 4, Week 8)
[2]Skin moisture content (Screening, Week 0, Week 4, Week 8)
Key secondary outcomes *Secondary outcomes
[1]Visual evaluation (Screening, Week 0, Week 4, Week 8)

*Other index
[1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8)

*Safety evaluation
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8)
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8)
[3]Hematologic test (Screening, Week 0, Week 8)
[4]Blood biochemical test (Screening, Week 8)
[5]Blood test (Screening, Week 0, Week 8)
[6]Urine analysis (Screening, Week 0, Week 8)
[7]Doctor's questions (Screening, Week 0, Week 4, Week 8)
[8]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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test food (8 weeks)
Interventions/Control_2 Oral ingestion of the placebo food A (8 weeks)
Interventions/Control_3 Oral ingestion of the placebo food B (8 weeks)
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 Male and Female
Key inclusion criteria [1]Japanese females aged 30-59 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals who are anxious about skin dryness.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who use a drug to treat a disease in the past 1 month.
[3]Individuals with skin disease, such as atopic dermatitis.
[4]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease.
[5]Individuals who contract or have a history of serious endocrine disease.
[6]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg.
[7]Individuals whose BMI is over 30.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[9]Individuals with serious anemia.
[10]Individuals who are sensitive to a test producer other foods, and medical products.
[11]Individuals who are or are possibly, or are lactating.
[12]Individuals who are alcoholism or mental disorders.
[13]Individuals who have a habit of smoking.
[14]Individuals whose bowel habit is irregular.
[15]Individuals whose life style will change during the test period.
[16]Individuals with probable seasonal allergy, such as pollinosis, during the test period.
[17]Individuals who will get sunburned during the test period (including winter sports like skiing and snowboarding).
[18]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.
[19] Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[20] Individuals who use cosmetics having a strong moisturizing effect or improving effect for wrinkle.
[21]Individuals who had been conducted an operation on the test spot in the past 6months.
[22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months.
[23]Individuals who are or whose family is engaged in healthy or functional foods.
[24]Individuals judged inappropriate for the study by the principal.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ono
Organization Medical Corporation Wakei-kai Medics Hongo Clinic
Division name Director
Zip code
Address 2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL 03-6801-9761
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd
Division name Administrative Department of Clinical Trials
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 r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization LG Household & Health Care Ltd
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Korea

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
2017 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
2017 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2017 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
2017 Year 02 Month 07 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029915

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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