UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of the intake of a test food on condition of skin.
Acronym	A study for the effect of the intake of a test food on condition of skin.
Scientific Title	A study for the effect of the intake of a test food on condition of skin.
Scientific Title:Acronym	A study for the effect of the intake of a test food on condition of skin.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the effects of intake of the test food on skin conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of skin condition (measurement time: 0, 4, 8weeks after ingestion of the test food)
Key secondary outcomes	-Evaluation by a questionnaire -Visual evaluation (measurement time: 0, 4, 8weeks after ingestion of the test food)

Base
Study type	Interventional

Study design
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 need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of placebo food for 8 weeks
Interventions/Control_2	Oral intake of active food 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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy female aged from 20 to 39 years old 2. Subjects who have dry skin. 3. Subjects who worries about a face becoming red in winter 4. Subjects who have sensitive skin awareness 5. Menstrual cycle is stable. 6. BMI is from 18.5 to 25.0
Key exclusion criteria	1. Subjects who are outpatients or were treated by doctor recently. 2. Subjects who take medicine (example: sleeping pills, anti-allergic drugs, hormone drugs, laxative, antiflatulent, and other medicines) 3. Subjects who have received a cosmetic medicine (cosmetic surgery, injection of collagen, laser treatment, etc.) 4. Subjects who have severe allergic disease as pollen allergy, rhinitis, atopic dermatitis. 5. Subjects who have possibilities for emerging allergy to foods and cosmetics. 6. Subjects who are pregnant or lactating, or planned to become pregnant in the near future. 7. Current smoker 8. Subjects who are participate in the other clinical studies 9. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kumiko Ito M.D.
Organization	Medical Corporation Association Ouryokukai Nihonbashi Sakura Clinic
Division name	Director
Zip code
Address	Inamura Building 5th Floor 1-9-2 Kayabacho, Nihonbashi, Chuo-ku Tokyo 103-0025
TEL	+81-3-6661-9061
Email	k-ito@ouryokukai.jp

Public contact
1st name of contact person	1st name Middle name Last name Kazumi Naganuma
Organization	DRC Co., Ltd.
Division name	Product Testing Department
Zip code
Address	No.9 Tabuchi Bldg. 5F, 2-10-31, Higashi-Temma, Kita-ku, Osaka, JAPAN
TEL	+81-6-6882-1130
Homepage URL
Email	naganuma@drc-web.co.jp

Sponsor
Institute	DRC Co., Ltd.
Institute
Department

Funding Source
Organization	Kao 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	DRC株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 18 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	2018 Year 09 Month 19 Day
Date of IRB	2018 Year 09 Month 19 Day
Anticipated trial start date	2018 Year 11 Month 22 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 01 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039116