UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation study of skin character and condition using wearable skin biosensors
Acronym	Study of wearable skin biosensors
Scientific Title	Evaluation study of skin character and condition using wearable skin biosensors
Scientific Title:Acronym	Study of wearable skin biosensors
Region	Japan

Condition
Condition	Skin disease
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to clarify the significance of biological information for skin resistance value that can be evaluated by using wearable biosensors with gold nano-mesh electrode.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the correlation between the skin resistance value using wearable biosensors and the amount of TEWL and stratum corneum hydration with existing measuring instruments.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	to recruit research participants for people over 20 years old. to Include the participation of those who have skin diseases in the past and present.
Key exclusion criteria	1) Person with serious skin disease at the test area 2) Person with severe heart and muscle disease 3) Person who has metal allergy
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masayuki Middle name Last name Amagai
Organization	Keio University School of Medicine
Division name	Dermatology department
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3823
Email	amagai@keio.jp

Public contact
Name of contact person	1st name Keiji Middle name Last name Tanese
Organization	Keio University School of Medicine
Division name	Dermatology department
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3823
Homepage URL
Email	tanese@a3.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Dermatology department in Keio University School of Medicine, and Department of Electrical and Electronic Engineering in School of engineering of the university of Tokyo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Electrical and Electronic Engineering, School of Engineering, the University of Tokyo
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 (62014)
Email	med-rinri-jimu@adst.keio.ac.jp

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

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 04 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 03 Month 14 Day
Date of IRB	2019 Year 06 Month 04 Day
Anticipated trial start date	2019 Year 06 Month 06 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective research

Management information
Registered date	2019 Year 06 Month 03 Day
Last modified on	2020 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041994