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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031842
Receipt No. R000036362
Scientific Title Effects of environmental changes on the skin.
Date of disclosure of the study information 2018/03/22
Last modified on 2019/09/24

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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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