UMIN-ICDS Clinical Trial

Public title

A study to evaluate the effects of food containing plant-derived ingredients on the skin condition

Acronym

A study to evaluate the effects of food on the skin condition

Scientific Title

A study to evaluate the effects of food containing plant-derived ingredients on the skin condition

Scientific Title:Acronym

A study to evaluate the effects of food on the skin condition

Region

Japan

Condition

Not applicable

Classification by specialty

Clinical immunology	Dermatology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the effects of food containing plant-derived ingredients on the skin condition and allergy-related symptoms.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Stratum corneum hydration

Key secondary outcomes

Transepidermal water loss
Skin image analysis
Blood analysis
Sebum analysis
Stratum corneum analysis
Questionnaire

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of active food once a day for 8 weeks.

Interventions/Control_2

Intake of placebo food once a day for 8 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

Age-lower limit

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Female

Key inclusion criteria

1)Females aged 20 to 59 years old at the time of informed consent.
2)Those who have subjective symptoms of dry, red and itchy skin.
3)Those who have past diagnosis of allergic diseases or subjective allergy-related symptoms.
4)Those who are judged appropriate by the study director or person in charge.

Key exclusion criteria

1) Those who currently attend a clinic for treatment of skin diseases.
2) Those who currently attend a clinic for treatment of allergic diseases.
3) Those who attend a clinic for treatment of seasonal rhinitis.
4) Those who have experienced allergic symptoms due to the intake of certain foods.
5) Those who attend or attended a clinic within a month before the trial for treatment of the diseases which are considered to influence the outcome.
6) Those who have been infected with viruses of hepatitis B or C, syphilis or HIV.
7) Those who use drugs which are considered to influence the outcome within two weeks before the trial.
8) Those who regularly take certain supplements or have plan to take them during the trial period.
9) Those who have excessive sunburn on the test sites.
10) Those who have experienced cosmetic operation or are going to go to beauty salon during the test period.
11) Those who plan to participate in the other clinical trial during the trial period.
12) Those whose BMI is less than 18.5, or over 30.
13) Heavy drinkers.
14) Smokers
15) Those who are currently pregnant or breastfeeding, or wish to become pregnant during the trial period.
16) Those who have the fever or respiratory symptoms in themselves or their family living together, or have close contact with the persons infected with COVID-19 within two weeks before the trial.
17) Those who are judged not appropriate by the study director or person in charge.

Target sample size

50

Name of lead principal investigator

1st name	Koichi
Middle name
Last name	Misawa

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7268

Email

misawa.koichi@kao.com

Name of contact person

1st name	Yoshie
Middle name
Last name	Shimotoyodome

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

131-8501

Address

2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN

TEL

+81-3-5630-7268

Homepage URL

Email

shimotoyodome.yoshie@kao.com

Institute

Kao Corporation

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Macromill, Inc.
Juntendo University

Name of secondary funder(s)

Organization

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-9064

Email

morisaki.naoko@kao.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

花王株式会社（東京都）

Date of disclosure of the study information

2022

Year

12

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

11

Month

15

Day

Date of IRB

2022

Year

11

Month

15

Day

Anticipated trial start date

2023

Year

01

Month

10

Day

Last follow-up date

2023

Year

04

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

12

Month

26

Day

Last modified on

2022

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056843