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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015422
Receipt No. R000017935
Scientific Title Lowering of blood pressure and improvement of endothelial dysfunction by UVB therapy
Date of disclosure of the study information 2015/10/14
Last modified on 2016/10/14

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Basic information
Public title Lowering of blood pressure and improvement of endothelial dysfunction by UVB therapy
Acronym UVB effect on blood pressure
Scientific Title Lowering of blood pressure and improvement of endothelial dysfunction by UVB therapy
Scientific Title:Acronym UVB effect on blood pressure
Region
Japan

Condition
Condition Patients with psoriasis, atopic dermatitis, and other diseases who need UVB therapy.
Classification by specialty
Medicine in general Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of UVB on blood pressure and endothelial dysfunction by modulating immune system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Blood Pressure
Key secondary outcomes endotherial function

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
30 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with psoriasis, atopic dermatitis, other diseases who need UVB therapy.
Key exclusion criteria UVB therapy within 6 months
liver disease
kidney disease
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken-ichi Hirata
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
TEL 078-382-5846
Email hiratak@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Sasaki
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
TEL 078-382-5846
Homepage URL
Email nao10@mrh.biglobe.ne.jp

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department

Funding Source
Organization non
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
Address
Tel
Email

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
2015 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We include 12 patients with skin diseases who started UVB therapy. We could follow 8 patients in 12.
UVB improved blood pressure in 3 patinets with hypertension. We stopped recruitment and now are preparing for the paper.
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 Completed
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 10 Day
Date analysis concluded
2016 Year 05 Month 10 Day

Other
Other related information Observational study.
We include patients with psoriasis, atopic dermatitis, or other skin diseases who go to or are in the Kobe university hospital for receiving UVB therapy and provide oral and written informed consent. Trial recruitment began in March 2014 and will be completed in March 2016.
We exaimine blood pressure, endothelial function, and inflammatory markers.

Management information
Registered date
2014 Year 10 Month 13 Day
Last modified on
2016 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017935

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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