UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and usefulness of the wearable device for skin bioinstrumentation
Title of the study (Brief title)	Evaluation of safety and usefulness of the wearable device
Region	Japan

Condition
Condition	1) Healthy adult 2) The person given informed consent in writing
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In recent years, the wearable device provides an important role in the measurement of the vital function. We developed the nano-mesh device which had breathability newly for the purpose of there was little feeling of wearing and getting the device which a measurement objectified the sense of a difficult person conventionally and could display. When gold nano mesh is stuck on skin, confirm whether you do not adversely affect skin. In addition, We perform an examination in comparison with the conventional matrix about influence on skin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of an allergic reaction and a primary irritant reaction, based on the criteria of the International Contact Dermatitis Research Group after seven days of an examination.
Key secondary outcomes	Evaluation of the influence to the three-dimensional shape of the skin (roughness, irregularity, etc.)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	to confirm the adverse effect, when a newly developed wearable device are loaded on the skin
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	Healthy adult volunteers who declare the consent in writing for participating in this study.
Key exclusion criteria	The person with any severe skin symptoms in the study-site and with a serious cardiac and/or muscular disease. The person who have a metal allergy.
Target sample size	20

Research contact person
Name of lead principal investigator	Tamotsu Ebihara
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Sinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3823
Email	ebitamo@yahoo.co.jp

Public contact
Name of contact person	Tamotsu Ebihara
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Sinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3823
Homepage URL
Email	ebitamo@yahoo.co.jp

Sponsor
Institute	Department of Dermatology, Keio University School of Medicine
Institute
Department

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

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	2016 Year 06 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.nature.com/nnano/journal/vaop/ncurrent/full/nnano.2017.125.html?foxtrotcallback=true
Results
Other related information

Management information
Registered date	2016 Year 06 Month 20 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026077