UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038976 |
|---|---|
| Receipt number | R000044444 |
| Scientific Title | Efficacy of narrowband ultraviolet B phototherapy for patients with intractable pruritus cutaneus |
| Date of disclosure of the study information | 2020/04/20 |
| Last modified on | 2019/12/25 09:55:07 |
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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
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
kikumi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044444
