UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034004
Receipt number R000038769
Scientific Title Whitening effect of the supplement and cosmetics when used alone compared to simultaneously
Date of disclosure of the study information 2018/09/03
Last modified on 2019/02/01 17:44:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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

Condition

Healthy person

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

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

Key secondary outcomes

VISIA image analysis
Questionnaire


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL 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

うえのあさがおクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 03 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 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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name