UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of symptoms and physiological abnormality in allergic skin disease on QOL and work impairment.
Title of the study (Brief title)	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	HIROYUKI MUROTA
Organization	Osaka university
Division name	Dept. of dermatology
Address	2-2, Yamadaoka, Suita, Osaka
TEL	0668793031
Email	h-murota@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	0668795111
Organization	Osaka univeristy
Division name	Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005036