UMIN-CTR Clinical Trial

Basic information
Public title	A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Acronym	A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Scientific Title	A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Scientific Title:Acronym	A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and skin moisturizing effect of intake of test food for 8 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Water content of stratum corneum
Key secondary outcomes	Transepidermal water loss

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of a test food per day for 8 consecutive weeks
Interventions/Control_2	Intake of a placebo food per day for 8 consecutive 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	30 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	1.Healthy females from 30 to 49 years of age 2.Subjects who are aware of skin dryness and lower level of water content of stratum corneum
Key exclusion criteria	Subjects 1. who constantly use medicine, health food and general food that contain the ingredient involved in this study 2.who usually take a food, medicine, functional food, etc. which would affect skin condition 3.who have got cosmetic surgery which would affect the targeted skin 4.who have got cosmetic surgery or hormone therapy which would affect the skin other than targeted skin within 1 year before the screening test 5.who have got esthetic treatment would affect the targeted skin within 1 month before the screening test or plan the act 6.who have had ultraviolet exposure within 1 month before the screening test or plan to do 7.who wash the body using a nylon towel, etc. which provides strong skin irritation 8.who usually use bath additives 9.who have the wounds or inflammatory diseases which would affect the targeted skin 10.who have had a symptom of pollinosis during between January to April in the past 3 years or who are expected to have allergic symptoms on the skin during this study 11.who feel skin roughness on the targeted skin around the menses 12.who work on a pre-dawn shift or on night duty more than 2 times during this study 13.who are planning to go overseas 14.who have asthma or would have asthma during this study 15.who have serious diseases or medical history 16.who have allergic reaction related to this study 17.who have diseases under treatment affecting this study or who have medical history of serious disease requiring medication 18.who are judged inappropriate for the study according to the results of screening test 19.who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study 20.who are pregnant or lactating, or plan to become pregnant or lactate during this study 21.who are judged as unsuitable for the study due to lifestyle questionnaire 22.who are judged as unsuitable for the study by investigator for other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazuya Middle name Last name Souda
Organization	SHINMEI KITCHEN Co., LTD.
Division name	Management department, Production section
Zip code	650-0023
Address	6-1-21 Sakaemachi-dori, Chuo-ku, Kobe, Hyogo
TEL	078-371-2426
Email	souda-kazuya@akafuji.co.jp

Public contact
Name of contact person	1st name Kyohei Middle name Last name Hashimoto
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.hashimoto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	SHINMEI KITCHEN Co., LTD.
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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 19 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	50
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	2019 Year 12 Month 12 Day
Date of IRB	2019 Year 12 Month 12 Day
Anticipated trial start date	2020 Year 01 Month 20 Day
Last follow-up date	2020 Year 04 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 17 Day
Last modified on	2020 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044439