UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004283 |
|---|---|
| Receipt number | R000005036 |
| Scientific Title | The impact of symptoms and physiological abnormality in allergic skin disease on QOL and work impairment. |
| Date of disclosure of the study information | 2010/09/28 |
| Last modified on | 2018/12/31 09:07:50 |
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Basic information
Public title
The impact of symptoms and physiological abnormality in allergic skin disease on QOL and work impairment.
Acronym
The impact of allergic skin disease on patients' QOL
Scientific Title
The impact of symptoms and physiological abnormality in allergic skin disease on QOL and work impairment.
Scientific Title:Acronym
The impact of allergic skin disease on patients' QOL
Region
| Japan |
Condition
Condition
certain dermatoses including allergy and hidrosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is well known that symptoms and physiological abnormality in certain allergic diseases affects patients QOL and work/classroom/daily activity impairment. This study is conducted to validate such aspects.
Basic objectives2
Others
Basic objectives -Others
observation test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) sudomotor function
b) evaluation of intensity of itch by PAIN VISION.
c) questionnaire survey for satisfaction level of their treatment
d) visual analogue scale for itch
e) Skindex-16 (QOL)
f) Ped's QL (QOL)
g) WPAI questionnaire
h) State-Trait Anxiety Inventory-Form
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
| 8 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a) chief complaint with "pruritus"
b) over 8 years old, and regardless of gender
c) regardless of in- and out patients
Key exclusion criteria
1) patients with severe liver dysfunction
2)patients with a history of epilepsy
3) patients with drug allergy for antihistamines
4) excluding at a physician's direction
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROYUKI MUROTA |
Organization
Osaka university
Division name
Dept. of dermatology
Zip code
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668793031
h-murota@derma.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | 0668795111 |
Organization
Osaka univeristy
Division name
Dermatology
Zip code
Address
2-2, Suita
TEL
0668795111
Homepage URL
h-murota@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka univeristy
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
When it can be gotten to agree at the first medical examination, evaluation items, which appeared in the methods section, will be observed on the first, second, and third visits.
Management information
Registered date
| 2010 | Year | 09 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005036
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
