UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009452 |
|---|---|
| Receipt number | R000010955 |
| Scientific Title | Research for long term prognosis of severe cutaneous adverse reaction |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/12/17 14:30:54 |
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Basic information
Public title
Research for long term prognosis of severe cutaneous adverse reaction
Acronym
Research for long term prognosis of severe cutaneous adverse reaction
Scientific Title
Research for long term prognosis of severe cutaneous adverse reaction
Scientific Title:Acronym
Research for long term prognosis of severe cutaneous adverse reaction
Region
| Japan |
Condition
Condition
severe cutaneous adverse reaction
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to survey long term prognosis of severe cutaneous adverse reaction by mail. The patients who administered in our hospital since 1998 till 2011.
Basic objectives2
Others
Basic objectives -Others
Survey of prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long term prognosis of severe cutaneous adverse reaction will be assessed.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The severe cutaneous adverse reaction patients who administered in our hospital will be involved.
Key exclusion criteria
The severe cutaneous adverse reaction patients who administered in our hospital, but still visiting our department will be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Azukizawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, 565-0871 JAPAN
TEL
06-6879-3031
azukizaw@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Azukizawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Dermatology
Zip code
Address
2-2, Yamadaoka, Suita, 565-0871 JAPAN
TEL
06-6879-3031
Homepage URL
azukizaw@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Research Grants (Research on Intractable Diseases) from Ministry of Health, Labor, and Welfare of Japan
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questions about involvement of eye, lung, kidney, gastrointestinal, heart, collagen diseases, tumor, herpes zoster, diabetes mellitus, thyroid, pemphigus, pemphigoid.
Management information
Registered date
| 2012 | Year | 12 | Month | 01 | Day |
Last modified on
| 2013 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010955
