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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023640
Receipt No. R000024086
Scientific Title Effects of a Test Food for Improvement of Skin Function
Date of disclosure of the study information 2016/08/16
Last modified on 2016/08/16

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Basic information
Public title Effects of a Test Food for Improvement of Skin Function
Acronym Effects of a Test Food for Improvement of Skin Function
Scientific Title Effects of a Test Food for Improvement of Skin Function
Scientific Title:Acronym Effects of a Test Food for Improvement of Skin Function
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 jelly food containing glucosylceramide on improvement of skin function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Transepidermal water loss (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12)
[2]Skin moisture content (Screening #1, Screening #2 & Week 0, Week 4, Week 8, Week 12)
[3]Skin viscoelasticity (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[4]Visual evaluation (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[5]Questionnaire survey on skin condition (Screening #2 & Week 0, Week 4, Week 8, Week 12)
Key secondary outcomes [1]Blood pressure, pulsation (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[2]Weight, body fat percentage, BMI (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[3]Doctor's questions (Screening #2 & Week 0, Week 4, Week 8, Week 12)
[4]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
Other
Interventions/Control_1 Oral ingestion of a test product containing glucosylceramide (10g per a day; 12 weeks)
Interventions/Control_2 Oral ingestion of a placebo not containing glucosylceramide (10g per 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]Japanese females aged 30-60 years
[2]Individuals who are healthy and are not suffered from a chronic malady
[3]Individuals who are anxious about skin dryness, sag, and tone
[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
[3]Individuals who contract or have a history of serious hepatopathy, kidney damage, heart disease and blood disease
[4]Individuals who contract or have a history of serious endocrine disease
[5]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[6]Individuals whose BMI is over 30
[7]Individuals with serious anemia
[8]Individuals who are sensitive to a test product or other foods, and medical products
[9]Individuals who are or are posslibly, or are lactating
[10]Individuals who have addiction to alcohol
[11]Individuals who have a habit of smoking
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[13]Individuals whose bowel habit is irregular
[14]Individuals whose life style will change during the test period
[15]Individuals whose skin is sensitive or who is chronically red-faced
[16]Individuals with skin disease, such as atopic dermatitis
[17]Individuals who would emerge seasonal allergay and use drugs (except eye drops and nose drops)
[18]Individuals who is too sensitive to cold
[19]Individuals who is busy to their own work, housework or child care and neglect skin care
[20]Individuals who cannot avoid daylight exposure during the test period
[21]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 months or will ingest those foods during the test period
[22]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months
[23]Individuals who use cosmetics having a strong moisturizing effect or improvintg effect for wrinkle
[24]Individuals who had been conducted an operation on the test spot
[25]Individuals who participated in other clinical studies in the past 3 months
[26]Individuals judged inappropriate for the study by the principal
Target sample size 60

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 Aishitoto 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
2016 Year 08 Month 16 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 01 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 15 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 08 Month 16 Day
Last modified on
2016 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024086

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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