UMIN-CTR Clinical Trial

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
Institute	FANCL Corporation
Institute
Department

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
URL(English)	https://upload.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

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