UMIN-CTR Clinical Trial

Basic information
Public title	Analyses of the skin molecules in the patient of atopic dermatitis.
Acronym	Analyses of the skin molecules in the patient of atopic dermatitis.
Scientific Title	Analyses of the skin molecules in the patient of atopic dermatitis.
Scientific Title:Acronym	Analyses of the skin molecules in the patient of atopic dermatitis.
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the skin molecules in the patients of atopic dermatitis.
Basic objectives2	Others
Basic objectives -Others	The observational study the relationship between skin molecules and status of atopic dermatitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between skin molecules and status of atopic dermatitis.
Key secondary outcomes	The relationship between skin molecules and questionnaires.

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	59 years-old >=
Gender	Male
Key inclusion criteria	1.Japanese male panelists who are 20-59 years old. 2.Panelists with atopic dermatitis more than mild condition. 3.Panelists who have normal weight (BMI: Between 18.5 and 25.0) 4.Panelists who agree to have their typical daily routines.
Key exclusion criteria	1.Panelists who use the steroid and immunosuppressant in face for more than 2 weeks during a month. 2.Panelists who used the antibiotics in the last 2 weeks. 3.Panelists who have the disease, such as diabetes, affecting on this study. 4.Panelists who use the drugs affecting on this study. 5.Panelists who have undergone some beauty treatments on their faces. 6.Panelists participating in, or scheduled to participate in, another study during the study period. 7.Panelists who smoke.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshito Takahashi
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	5-3-28, Kotobuki-machi, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL	0465-34-6116
Email	takahashi.yoshito@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takayoshi Inoue
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	inoue.takayoshi@kao.co.jp

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	株式会社インフォワード（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 23 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	2017 Year 05 Month 23 Day
Date of IRB	2017 Year 05 Month 23 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Panelists will be recruited by Inforward, inc.

Management information
Registered date	2017 Year 05 Month 09 Day
Last modified on	2019 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031267