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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024845
Receipt No. R000028531
Scientific Title Effects of the Test Food (HB-h009) on Female's Skin Condition
Date of disclosure of the study information 2016/11/17
Last modified on 2017/03/12

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Basic information
Public title Effects of the Test Food (HB-h009) on Female's Skin Condition
Acronym Effects of the Test Food on Female's Skin Condition
Scientific Title Effects of the Test Food (HB-h009) on Female's Skin Condition
Scientific Title:Acronym Effects of the Test Food on Female's Skin Condition
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 the test food (HB-h009) on female's skin condition.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Colour difference (Week 0, Week 4, Week8)
Key secondary outcomes *Secondary outcomes
[1]Blood flow measurement with laser doppler (Week 0, Week 4, Week 8)
[2]Observation for skin condition by a specialist (Week 0, Week 4, Week 8)

*Safety
[1]Diagnosis by doctors (Week 0, Week 4, Week 8)
[2]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

*Other outcome
Peeling of horny cell layer (Week 0, Week 4, Week 8)

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 (1 pill in a day; 8 weeks)
Interventions/Control_2 Oral intake of the placebo product (1 pill in a day; 8 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
55 years-old >
Gender Female
Key inclusion criteria [1]Females aged 35-49 years
[2]Individuals who are healthy and have no chronic physical disease including skin disease
[3]Individuals who are concerning on her dull skin
[4]Individuals who are concerning on her blood circulation of the limbs
[5]Individuals whose menstrual cycle is normal or health condition is stable after menopause
[6]Individuals whose written informed consent has been obtained
[7]Individuals who can have an examination in a designated day
[8]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 are sensitive to test product or other foods, and medical products
[9]Individuals who are or are possibly pregnant, or are lactating
[10]Individuals who have an addiction to alcohol or a mental illness
[11]Individuals who are a smoker
[14]Individuals whose bowel habit is irregular
[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 participated in other clinical studies in the past 3 months
[21]Individuals judged inappropriate for the study by the principal
Target sample size 50

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
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 Development for 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 info@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization Hayashibara 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 11 Month 17 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 24 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 17 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 15 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028531

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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