UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on the efficacy of BVVR001 (development code)
Title of the study (Brief title)	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	Akihiko Fujii
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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	Daiji Kagawa
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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