UMIN-CTR Clinical Trial

Basic information
Public title	A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Acronym	A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Scientific Title	A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Scientific Title:Acronym	A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Region	Japan

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

Objectives
Narrative objectives1	Verify the association with sensitive skin consciousness and inflammatory conditions.
Basic objectives2	Others
Basic objectives -Others	Survey on actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	association with sensitive skin consciousness and inflammatory conditions
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	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	-Subjects have abnormalities on the skin of the test site (face, inside forearm) -Subjects attend medical institutions at all times -Subjects use medicines on a 2-day- and 7-day-long -Subjects have received cosmetic medicine -Subjects judged by the person in charge of the examination to be inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Tojo
Organization	Kao Corporation
Division name	Skin Care Products Research Laboratory
Zip code	1318501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL	+81-3-5630-9557
Email	tojo.kaori@kao.com

Public contact
Name of contact person	1st name Noriko Middle name Last name Haketa
Organization	Kao Corporation
Division name	Skin Care Products Research Laboratory
Zip code	1318501
Address	2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL	+81-3-5630-7286
Homepage URL
Email	haketa.noriko@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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
Tel	+81-3-5630-7263
Email	morisaki.naoko@kao.com

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	デルマラボ株式会社（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 02 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 24 Day
Date of IRB	2020 Year 11 Month 24 Day
Anticipated trial start date	2020 Year 11 Month 30 Day
Last follow-up date	2020 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 10 Month 31 Day

Other
Other related information	Verify the association with sensitive skin consciousness and inflammatory conditions.

Management information
Registered date	2020 Year 12 Month 02 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048642

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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