UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015422 |
|---|---|
| Receipt number | 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 16:54:48 |
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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
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
nao10@mrh.biglobe.ne.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Cardiovascular Medicine, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
