UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of narrowband ultraviolet B phototherapy for patients with intractable pruritus cutaneus
Acronym	Efficacy of phototherapy for intractable pruritus cutaneus
Scientific Title	Efficacy of narrowband ultraviolet B phototherapy for patients with intractable pruritus cutaneus
Scientific Title:Acronym	Efficacy of phototherapy for intractable pruritus cutaneus
Region	Japan

Condition
Condition	intractable pruritus cutaneus
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of phototherapy for intractable pruritus cutaneus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Numerical Rating Scale (NRS)
Key secondary outcomes	1 Clinical photograph(at the beginning, the middle, and the end of the treatment) 2 Exploration of the biomarkers(proinflammatory cytokine etc.) with residual specimen of serum (at the beginning, the middle, and the end of the treatment) 3 MRI images

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	Subjects must have met all of the following inclusion criteria: 1 Patients with other internally or externally treatment-resistance pruritus cutaneus 2 Patients with pruritus cutaneus, prurigo, or atopic dermatitis 3 Patients under the phototherapy over once a week 4 Age >= 20, written approval of patient
Key exclusion criteria	Patients with photodermatosis
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kyoko Middle name Last name Ikumi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
Zip code	467-8601
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL	052-853-8261
Email	kikumi@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Kyoko Middle name Last name Ikumi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
Zip code	467-8601
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL	052-853-8261
Homepage URL
Email	kikumi@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Management Center,Nagoya City University Hospital
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel	052-851-5511
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	名古屋市立大学病院　Nagoya City University Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 20 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 12 Month 31 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Efficacy of phototherapy intractable pruritus cutaneus is evaluated by the following. Numerical Rating Scale(NRS) Clinical phtograph(at the beginning, the middle, and the end of the treatment) Exploration of the biomarkers (proinflammatory cytokine etc.) with residual specimen of serum (at the beginning, the middle, and the end of the treatment) MRI images

Management information
Registered date	2019 Year 12 Month 24 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044444