UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of skin prick test using with histamine as positive control
Title of the study (Brief title)	Histamine and skin prick test
Region	Japan

Condition
Condition	Allergic diseases including bronchial asthma, food allergy, atopic dermatitis and allergic thinitis
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of accuracy of diagnosis of allergens with and without histamine as positive control
Basic objectives2	Others
Basic objectives -Others	Validation of strength of positive response to histamine Investigation into frequency of hyper-sensitivity and hypo-sensitivity to histamine
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Positive skin prick test(SPT)
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Physician-suspected patients with IgE-mediated allergic reactions, such as bronchial asthma, allergic rhinitis, allergic conjunctivitis, food allergy, anaphylaxis, urticaria, drug allergy and latex allergy etc.
Key exclusion criteria	Patients without the intact skin to perform SPT Patients with the skin untreated with steroid ointment to perform SPT Patients with steroid IV in one month Patients with immunosuppressive drug treatment in one month Patients with antiallergic drug po in one week Patients with antihistamine po in one week
Target sample size	250

Research contact person
Name of lead principal investigator	Miwa Shinoahra
Organization	Ehime University Hospital
Division name	Pediatrics
Address	454 Shitsukawa, Toon-City, Ehime
TEL	089-960-5320
Email	shinohara.miwa.vv@ehime-u.ac.jp

Public contact
Name of contact person	Miwa Shinoahra
Organization	Ehime University Hospital
Division name	Pediatrics
Address	454 Shitsukawa, Toon-City, Ehime
TEL	089-960-5320
Homepage URL
Email	shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

Funding Source
Organization	Ehime University Hospital
Organization
Division
Category of Funding Organization	Other
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	2017 Year 04 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2017 Year 04 Month 15 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	Unpublished
URL releasing results
Results
Other related information	Skin prick tests using with bifurcated needles.

Management information
Registered date	2017 Year 04 Month 13 Day
Last modified on	2018 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024510