UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028964
Receipt number R000033146
Scientific Title A study on efficacy of HB35FA against UV-induced skin inflammation.
Date of disclosure of the study information 2017/09/01
Last modified on 2019/12/20 12:14:19

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Basic information

Public title

A study on efficacy of HB35FA against UV-induced skin inflammation.

Acronym

Evaluation of beauty ingredient for skin

Scientific Title

A study on efficacy of HB35FA against UV-induced skin inflammation.

Scientific Title:Acronym

Evaluation of beauty ingredient for skin

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the anti-inflammatory effect of HB35FA against UV-induced skin inflammation for healthy male

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

-Evaluation of anti-inflammatory effect after 3 weeks of HB35FA administration.

Key secondary outcomes

-Change of inflammatory markers in the stratum corneum after 3 weeks of HB35FA administration.
-Change of fecal microbiome and metabolome after 4 weeks of HB35FA administration.
-Change of blood inflammatory markers after 4 weeks of HB35FA administration.


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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

-Oral administration of an active drink every day for 4 weeks.
-A 4-week washout period.
-Oral administration of a placebo drink every day for 4 weeks.

Interventions/Control_2

-Oral administration of a placebo drink every day for 4 weeks.
-A 4-week washout period.
-Oral administration of an active drink every day 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 male

Key exclusion criteria

-Subjects with photosensitive dermatitis.
-Subjects with clinically-significant disorder at the test site
-Subjects who go to hospital regularly or routinely taking oral medicine for disease: gastrointestinal system, liver, kidney, heart, and blood pressure.
-Subjects who are routinely taking oral medicine for sunburn, chloasma, and freckles.
-Subjects who are 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 Shinobu Mori

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

+81-285-68-7460

Email

mori.shinobu@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Kuwano

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

+81-285-68-7459

Homepage URL


Email

kuwano.tetsuya@kao.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Self funding

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(栃木県)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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 08 Month 24 Day

Date of IRB

2017 Year 08 Month 24 Day

Anticipated trial start date

2017 Year 09 Month 04 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 12 Month 06 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 01 Day

Last modified on

2019 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033146


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name