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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004283
Receipt No. 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

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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
Email 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
Email h-murota@derma.med.osaka-u.ac.jp

Sponsor
Institute Osaka univeristy
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005036

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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