UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027751 |
|---|---|
| Receipt number | 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 18:01:53 |
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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
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
kagawa.daiji@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031802
