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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036155
Receipt No. R000041179
Scientific Title Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for atopic dermatitis.
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/11

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Basic information
Public title Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for atopic dermatitis.
Acronym Study on the utility of the short wavelength cut filter attached to the phototherapy device for atopic dermatitis.
Scientific Title Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for atopic dermatitis.
Scientific Title:Acronym Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for atopic dermatitis.
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the efficacy of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skin pigmentation of irradiation area
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 attached the short wavelength cut filter
Interventions/Control_2 not attached the short wavelength cut filter
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
16 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria -Atopic dermatitis patients who are poor controlled with topical anti-inflammatory agent, oral antihistamine agent and moisturizing agent.
-Patient who is candidates for 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 20

Research contact person
Name of lead principal investigator
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
Email amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person
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
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.
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 0528587215
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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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