UMIN-CTR Clinical Trial

Public title

Whitening effect of the supplement and cosmetics when used alone compared to simultaneously

Acronym

Whitening effect of the supplement and cosmetics when used alone compared to simultaneously

Scientific Title

Whitening effect of the supplement and cosmetics when used alone compared to simultaneously

Scientific Title:Acronym

Whitening effect of the supplement and cosmetics when used alone compared to simultaneously

Region

Japan

Condition

Healthy person

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the whitening effect of the test cosmetics and test foods when used alone and simultaneously.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Skin color quantification by spectrophotometer
Skin color evaluation by skin color scale

Key secondary outcomes

VISIA image analysis
Questionnaire

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Other

Interventions/Control_1

Test food (Intake priod:12 weeks)

Interventions/Control_2

Test cosmetics (use priod:12 weeks)

Interventions/Control_3

Test food and Test cosmetics (use priod:12 weeks)

Interventions/Control_4

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

55

years-old

>

Gender

Female

Key inclusion criteria

1)Japanese healthy females aged 35 to 54 years at the time of informed consent.
2)Healthy subjects who do not have chronic physical disorders,including skin diseases.
3)Subjects who have senile pigment freckle on face.
4)Subjects who agree to participate in the study on one's own will.
5)Subjects who can visit the designated medical institution on specified date during the study.
6)Subjects who are judged as reasonable participants for the study by the doctor in charg.

Key exclusion criteria

1)Subjects who have certain diseases and undergoing drug treatment on medication.
2)Subjects who are currently using medication.
3)Subjects who have taken medicines for the purpose of treating diseases within the past one month.
4)Subjects who are suffering or suffered from serious disease.
5)Subject who have skin disease.
6)Subjects who have sensitive skin.
7)Subjects who have severe skin disorders on the face.
8)Subjects who have mole, acne vulgaris, erythema, capillary dilation at the measurement points.
9)Subjects who have may show allergic symptoms to cosmetics.
10)Subjects who may show severe allergic symptoms to the test foods.
11)Subjects who have alcoholism or other psychiatric disorders.
12)Subjects who have smoking habit.
13)Subjects who may change lifestyle habits during the test period.
14)Subjects who are unable to refrain from direct sunlight, during the test period.
15)Subjects who develop pollinosis and may use medication during the study period.
16)Subjects who used or will use of medications, health foods, supplements, which have skin whitening and skin improvement effects during the test period, or who have used any of the above within the past 3 months.
17)Subjects who used cosmetics or medication that may advocate the whitening effect within the past 3 months or who are planning to use them during the test period.
18)Subjects who had treatment history at the evaluation site within the past 6 months.
19)Subjects who are pregnant or breast-feeding.
20)Subjects who are participating in other clinical studies or who have participated in other clinical studies within the past 3 months.
21)Subjects who or whose family work for a company that develops, manufactures or sells health foods, and cosmetics.
22)Subjects who are judged as unsuitable participant for the study by the doctor and the investigator in charge for other reasons.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kei Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3755

Email

ke-yui@fancl.co.jp

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

FANCL Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

うえのあさがおクリニック（東京都）

Date of disclosure of the study information

2018

Year

09

Month

03

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

Completed

Date of protocol fixation

2017

Year

08

Month

07

Day

Date of IRB

Anticipated trial start date

2018

Year

09

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

09

Month

03

Day

Last modified on

2019

Year

02

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038769