UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the usefulness of High speed art scannar for the skin disease
Acronym	Examination of the usefulness of High speed art scannar for the skin disease
Scientific Title	Examination of the usefulness of High speed art scannar for the skin disease
Scientific Title:Acronym	Examination of the usefulness of High speed art scannar for the skin disease
Region	Japan

Condition
Condition	skin disease
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the image which was taken with the High speed art scanner with the image e which was taken with camera and examine usefulness of the High speed art scanner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Three-dimensional impression of the image Vividness of the image Match degree of the focus
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	1 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	the person with the skin disease on limbs
Key exclusion criteria	Photosensitivity Photosensitivity epilepsy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Kato
Organization	TOKYO METROPOLITAN BOKUTOH HOSPITAL
Division name	Dermatology
Zip code	1308575
Address	4-23-15, Koutoubashi, Sumida-ku, Tokyo, Japan
TEL	+81-03-3633-6151
Email	katoderm@tmd.ac.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Kato
Organization	TOKYO METROPOLITAN BOKUTOH HOSPITAL
Division name	Department of dermatology
Zip code	1308575
Address	4-23-15, Koutoubashi, Sumida-ku, Tokyo, Japan
TEL	+81-03-3633-6151
Homepage URL
Email	katoderm@tmd.ac.jp

Sponsor
Institute	TOKYO METROPOLITAN BOKUTOH HOSPITAL Department of dermatology
Institute
Department

Funding Source
Organization	TOKYO METROPOLITAN BOKUTOH HOSPITAL Department of dermatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	TOKYO METROPOLITAN BOKUTOH HOSPITAL
Address	Koutoubashi, Sumida-ku, Tokyo, Japan
Tel	+81-03-3633-6151
Email	bo_rinsho_kenkyu@tmph.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	東京都立墨東病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	4
Results	The scanned image was more three-dimensional.
Results date posted	2021 Year 03 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Outpatients with hand lesions
Participant flow	Taking pictures with a camera and scanner
Adverse events	None
Outcome measures	How the image appears
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 12 Day
Date of IRB	2018 Year 03 Month 09 Day
Anticipated trial start date	2018 Year 03 Month 12 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	None

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2021 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036190