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

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 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


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

Value
https://center6.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