UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029083
Receipt No. R000033265
Scientific Title Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases
Date of disclosure of the study information 2017/09/11
Last modified on 2017/09/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases
Acronym Evaluation of usefulness of embedded programs for portable terminals such as smartphones in patients with inflammatory skin diseases
Scientific Title Research on the usefulness of embedded programs for portable terminals such as smartphones, aimed at grasping external conditions and skin conditions at home for patients with inflammatory skin diseases
Scientific Title:Acronym Evaluation of usefulness of embedded programs for portable terminals such as smartphones in patients with inflammatory skin diseases
Region
Japan

Condition
Condition Inflammatory skin diseases
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim for use in clinical application and research of a smartphone application
Basic objectives2 Others
Basic objectives -Others In this research, it is verified whether a smartphone application (tentative name: skin diary) can be a useful tool for grasping external treatment situation of a patient with atopic dermatitis, grasping skin condition, and correlation between lifestyle and subjective symptoms . By this research, if the usefulness of the smartphone application (skin diary) is demonstrated, we can aim at full-scale use of the smartphone application for clinical application and research while taking safety and ethical considerations into consideration.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Application input status of research collaborators, questionnaire evaluation after using the application by patients
Key secondary outcomes Evaluation of treatment situation at home atopic dermatitis patients based on application input results, evaluation of skin condition

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

Not applicable
Gender Male and Female
Key inclusion criteria Keio University Hospital Atopy outpatient clinic who does not meet the following exclusion criteria. The patient selection does not involve the treatment content or the degree of symptoms.
Key exclusion criteria 1) Those who can not use smartphone, those not accustomed to use.
2) Those who are judged to be difficult to cooperate with this research by research researcher or shared medical doctor from past hospitalization situation etc.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio University School of Medicine
Division name department of dermatology
Zip code
Address 35Shinano-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3823
Email ebitamo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio University School of Medicine
Division name department of dermatology
Zip code
Address 35Shinano-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3823
Homepage URL
Email ebitamo@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine, department of dermatology
Institute
Department

Funding Source
Organization Keio University School of Medicine, department of dermatology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Physical and Chemical Research, Medical Sciences Innovation Hub Program
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 慶應義塾大学病院皮膚科(東京)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 11 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
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information Test collaborators will enter data for more than 4 weeks. Regarding the input period of the test cooperator, in principle, it takes more than 4 weeks, but for the applicant, it is permitted to use up to 6 months.
The test cooperator responds to the questionnaire on feeling of use at the outpatient visit during the skin diary use period.

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.