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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027751
Receipt No. R000031802
Scientific Title A Study on the efficacy of BVVR001 (development code)
Date of disclosure of the study information 2017/06/14
Last modified on 2017/12/14

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Basic information
Public title A Study on the efficacy of BVVR001 (development code)
Acronym A Study on the efficacy of BVVR001 (development code)
Scientific Title A Study on the efficacy of BVVR001 (development code)
Scientific Title:Acronym A Study on the efficacy of BVVR001 (development code)
Region
Japan Australia

Condition
Condition Healthy adults
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of BVVR001 (development code) for the skin microcirculation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Objective indicators on skin microcirculation before and after ingestion of BVVR001 (development code) for 4 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 Prevention
Type of intervention
Food
Interventions/Control_1 BVVR001 (development code) ingestion
Twice a day (before bedtime and after wake-up) for 4 weeks
->
Washout for 5 weeks
->
Placebo ingestion
Twice a day (before bedtime and after wake-up) for 4 weeks
Interventions/Control_2 Placebo ingestion
Twice a day (before bedtime and after wake-up) for 4 weeks
->
Washout for 5 weeks
->
BVVR001 (development code) ingestion
Twice a day (before bedtime and after wake-up) for 4 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
59 years-old >=
Gender Male
Key inclusion criteria Healthy males
Key exclusion criteria -Subjects who have been suffered from a critical disease
-Subjects who take prescription medicine
-Subjects with the illness of a vascular function
-Subjects with atopic dermatitis, eczema and pollen allergy
-Subjects with food allergy
-Subjects with smoking habit
-Subjects who are in poor physical condition
-Subjects who have an abnormality of measurement skin site
-Subjects undergoing trauma in the measurement site
-Subjects who are influenced by the adhesive
-Subjects who participate in the other examinations which have an influence on this examination
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Fujii
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7458
Email fujii.akihiko@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiji Kagawa
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7458
Homepage URL
Email kagawa.daiji@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 花王株式会社栃木事業場(栃木県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 14 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 06 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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
2017 Year 06 Month 14 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=R000031802

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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