UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Acronym	Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Scientific Title	Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Scientific Title:Acronym	Exploratory research on the use of ultraviolet transmitting material pad for UV phototherapy device
Region	Japan

Condition
Condition	psoriasis vulgaris,cutaneous T cell lymphoma
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the usefulness and usability of the patient of UV transmitting elastic material pad for UV phototherapy device
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	exploratory research
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	-Patient who have experienced treatment with TheraBeam UV308mini and candidate for UV phototherapy
Key exclusion criteria	-Patient who is not candidates for phototherapy -Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation -Patients who are judged inappropriate to participate in the study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Morita Middle name Last name Akimichi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
Zip code	4678601
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL	052-853-8261
Email	amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Akimichi Middle name Last name Morita
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
Zip code	4678601
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL	052-853-8261
Homepage URL
Email	amorita@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology
Institute
Department

Funding Source
Organization	USHIO INC. ISHIZUKA GLASS CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel	052-858-7215
Email	clinical_research@med.nagoya-cu.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 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 01 Month 15 Day
Date of IRB	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 03 Month 01 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	Examination of the usefulness and usability of the patient of UV transmitting elastic material pad for UV phototherapy device

Management information
Registered date	2019 Year 03 Month 11 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041176