UMIN-CTR Clinical Trial

Public title

A study about the efficacy prediction of the whitening products by analysis of skin surface lipids component.

Acronym

A study about the efficacy prediction of the whitening products by analysis of skin surface lipids component.

Scientific Title

A study about the efficacy prediction of the whitening products by analysis of skin surface lipids component.

Scientific Title:Acronym

A study about the efficacy prediction of the whitening products by analysis of skin surface lipids component.

Region

Japan

Condition

Healthy adults

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To predict the whitening efficacy based on analysis of skin surface lipids.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of the melanin content in the facial skin after continuous use of each whitening products for 8 weeks.

Key secondary outcomes

Evaluation of the facial skin color and appearance after continuous use of each whitening products for 8 weeks.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Other

Interventions/Control_1

Apply 4 gram of the whitening essence A to the whole face, twice a day (morning and evening) for 8 weeks.

Interventions/Control_2

Apply 4 gram of the whitening essence B to the whole face, twice a day (morning and evening) for 8 weeks.

Interventions/Control_3

Apply 4 gram of the whitening essence C to the whole face, twice a day (morning and evening) for 8 weeks.

Interventions/Control_4

Apply 4 gram of the whitening essence D to the whole face, twice a day (morning and evening) for 8 weeks.

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Female

Key inclusion criteria

1.Healthy female aged from 35 to 49 years old.
2.Persons who can agree to participate in the study voluntarily in writing.
3.Persons who use UV care productsn all year round.
4.Persons who can agree to be taken several pictures including their face.
5.Persons who has no trouble in the skin of test sites (face, hands and upper arms).

Key exclusion criteria

1.Persons who take supplements or drinks that claim to have some whitening effects.
2.Persons who use cosmetics containing whitening ingredients or take medicines claiming whitening function.
3.Persons who have scratches or eczema on their face.
4.Persons who have a lot of acne or acne scars on their face.
5.Persons who participated within the past 6 months in a survey or clinical trial which affects the results of this study.
6.Subjects who have some disease that may affect the results of this study.
7.Persons who have allergic symptoms such as pollinosis on their face.
8.Persons who have skin symptoms such as atopic dermatitis and contact dermatitis.
9.Persons who tend to be induced skin inflammation by using of cosmetics or external stimuli such as changing temperature.
10.Persons who have symptoms of menopause.
11.Persons who are pregnant, may be pregnant or wish to become pregnant during the test period.
12.Persons who experienced medical cosmetic treatment.
13.Persons who is judged as unsuitable for the study by the investigator for other reasons.

Target sample size

150

Name of lead principal investigator

1st name	Yasuko
Middle name
Last name	Amano

Organization

Kao Corporation

Division name

R&D Skin Care Products Research

Zip code

131-8501

Address

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

TEL

+81-3-5630-9480

Email

amano.yasuko@kao.com

Name of contact person

1st name	Hiroki
Middle name
Last name	Yanagisawa

Organization

Kao Corporation

Division name

R&D Skin Care Products Research

Zip code

131-8501

Address

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

TEL

+81-3-5630-9829

Homepage URL

Email

yanagisawa.hiroki@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

Name of secondary funder(s)

Organization

Human Research Ethics Committee, Kao Corporation

Address

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

Tel

+81-70-3297-0969

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

インターフェイス株式会社（秋田県）

Date of disclosure of the study information

2020

Year

10

Month

19

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

2020

Year

10

Month

18

Day

Date of IRB

2020

Year

10

Month

19

Day

Anticipated trial start date

2020

Year

10

Month

20

Day

Last follow-up date

2020

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

10

Month

19

Day

Last modified on

2020

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048132