UMIN-CTR Clinical Trial

Basic information
Public title	Effects of environmental changes on the skin.
Acronym	Effects of environmental changes on the skin.
Scientific Title	Effects of environmental changes on the skin.
Scientific Title:Acronym	Effects of environmental changes on the skin.
Region	Japan

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

Objectives
Narrative objectives1	Evaluation effects of environmental changes on the skin properties and its function.
Basic objectives2	Others
Basic objectives -Others	Evaluation effects of environmental changes on the skin properties and its function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate to change and recovery in the forearm skin hydration with TEWL after 24-hour water exposure.
Key secondary outcomes	Evaluate to change and recovery in the forearm skin hydration with methyl nicotinates permeability, with packing values, with water profiles, the skin surface water content and under the water profiles area under the curve, and with quantification on pools area within cirsta cuites after 24-hour water exposure.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Water exposure/no treatment for 24 hours to the forearm skin
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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	-20-59 years old healthy adults -People who have non-troubled on their forearm skin.
Key exclusion criteria	-People who have dermatitis (atopic dermatitis etc.). -People under-medication. -People who have experience of skin troubled with occlusion. -People who is judged as "not eligible" by investigator. For example, those of sunburned, pigmentation, lots of hairs and significant skin contour by his mascule and blood vessel.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinobu Mori
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7443
Email	mori.shinobu@kao.com

Public contact
Name of contact person	1st name Middle name Last name Chie Fuse
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7443
Homepage URL
Email	fuse.chie@kao.com

Sponsor
Institute	Kao Corporation
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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 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 03 Month 07 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 03 Month 23 Day
Last follow-up date	2018 Year 10 Month 30 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 03 Month 22 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036362

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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