UMIN-CTR Clinical Trial

Basic information
Public title	Research to establish a system to utilize life-log information of patients with atopic dermatitis for medical treatment
Acronym	Skin-diary cloud research for atopic dermatitis patients
Scientific Title	Research on system development for integrating medical information with life-log information of atopic dermatitis patients and applying it to medical care
Scientific Title:Acronym	Clinical application study of life-log information of patients with atopic dermatitis
Region	Japan

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

Objectives
Narrative objectives1	Using the smartphone application "Skin Diary Cloud", we will build a personalized analysis method for life log data, and establish a patient / medical viewer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Input history and data to Skin-diary app
Key secondary outcomes	Evaluation of usability by questionnaire after implementation

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	As a rule, use the skin diary app daily for one year
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have their own smartphone and go to the atopy outpatient clinic at Keio University Hospital. The patients do not meet the following exclusion criteria. The nature of treatment and the degree of symptoms are not involved in patient selection.
Key exclusion criteria	1) Patients who cannot use smartphone. 2) Patients who are judged to be difficult to cooperate with this study by the investigator or the doctor based on past visits to the hospital. 3) Those who do not have a smartphone running on the OS that guarantees the operation of the skin diary app. (iOS11.0 or higher / Android6.0 or higher)
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Keishi Middle name Last name Tanese
Organization	Keio University School of Medicine
Division name	Dermatology department
Zip code	1608582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	tanese@keio.jp

Public contact
Name of contact person	1st name HIroshi Middle name Last name Kawasaki
Organization	Keio University School of Medicine
Division name	Dermatology department
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	hiroshi.z5@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Cabinet Office
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	keio@esct.bvits.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	東京都

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 15 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	Open public recruiting
Date of protocol fixation	2019 Year 12 Month 10 Day
Date of IRB	2020 Year 03 Month 16 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 13 Day
Last modified on	2020 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045368