UMIN-CTR Clinical Trial

Basic information
Public title	The influence that everyday skin care or dietary habits from time give in the measurement data using the onset of the skin disease and the Corner layer fluid volume measuring instrument since childhood.
Acronym	Skin examination
Scientific Title	The influence that everyday skin care or dietary habits from time give in the measurement data using the onset of the skin disease and the Corner layer fluid volume measuring instrument since childhood.
Scientific Title:Acronym	Skin examination
Region	Japan

Condition
Condition	none
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the influences of the lifestyle (skin care habits, exposure situation of sunlight) from childhood until now on onset of skin diseases and moisture level of skin stratum corneum.
Basic objectives2	Others
Basic objectives -Others	observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire about the lifestyle (skin care habits, exposure situation of sunlight) from childhood until now.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <=
Age-upper limit	22 years-old >=
Gender	Female
Key inclusion criteria	Person belong to Wayo Women's University with written consent of the participation after received explanation in writing about the study.
Key exclusion criteria	None
Target sample size	350

Research contact person
Last name of lead principal investigator	1st name Tekehiko Middle name Last name Kaneko
Organization	Wayo Women's University
Division name	Vice president
Zip code	272-0827
Address	2-3-1, kokubudai, ichikawa-shi, Chiba, 272-0827, Japan
TEL	047-371-1111
Email	t-kaneko@wayo.ac.jp

Public contact
1st name of contact person	1st name Yoshitaka Middle name Last name Ogaki
Organization	EBC&M LLC.
Division name	Clinical Business Department
Zip code	105-0011
Address	2-9-1, shibakoen, minato-ku, Tokyo, 105-0011, Japan
TEL	03-6435-3833
Homepage URL
Email	yoshitaka_ogaki@ebc-m.com

Sponsor
Institute	Non-profit Organization, Health Institute Research of Skin
Institute
Department

Funding Source
Organization	POLA Pharma INC.
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	Wayo Women's University
Address	2-3-1, kokubudai, ichikawa-shi, Chiba, 272-0827, Japan
Tel	047-371-1111
Email	t-kaneko@wayo.ac.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	2019 Year 04 Month 04 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	225
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 04 Month 20 Day
Date of IRB	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 10 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 12 Month 17 Day

Other

Other related information

The practice situation of the skin care from the young children period to date, a lot of customs of the meal intake decided to perform a study of searching what kind of influence the onset of an allergic disease and the skin disease had on the objective index indicating the skin state including the keratin fluid volume more. Specifically, I planned enforcement of the questionary survey about examination, an investigation into health condition of the skin by the dermatologist and a past lifestyle for female college students.

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

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041439