UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of the epicutaneous immunotherapy for food allergy -Selection of skin sticking device and allergen-
Acronym	Efficacy of the epicutaneous immunotherapy for food allergy
Scientific Title	Efficacy of the epicutaneous immunotherapy for food allergy -Selection of skin sticking device and allergen-
Scientific Title:Acronym	Efficacy of the epicutaneous immunotherapy for food allergy
Region	Japan

Condition
Condition	milk allergy
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy of the epicutaneous immunotherapy for food allergy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of intake of milk in oral food challenge within 4 weeks after 12 weeks of epicutaneous immunotherapy
Key secondary outcomes	Safety of epicutaneous immunotherapy (evaluation of side reaction)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Milk protein (allergen scratch Torii milk 0.05 ml) Transdermal exposure (sticking) should be done 3 times a week every 48 hours and, as a rule, continue for 12 weeks.
Interventions/Control_2	placebo Transdermal exposure (sticking) should be done 3 times a week every 48 hours and, as a rule, continue for 12 weeks.
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	3 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with milk allergy
Key exclusion criteria	Patients who are adrenalin contraindications Patients with serious systemic diseases such as immunodeficiency, severe heart disease, chronic infection, and malignancy Others who are deemed inappropriate by the research leader or co-worker
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kota Middle name Last name Hirai
Organization	Tokai University Hachioji Hospital
Division name	department of pediatrics
Zip code	192-0032
Address	1838 Ishikawa machi, Hachioji, Tokyo, Japan
TEL	042-639-1111
Email	hirai@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Yamaguchi
Organization	Tokai University Hachioji Hospital
Division name	department of pediatrics
Zip code	192-0032
Address	1838 Ishikawa machi, Hachioji, Tokyo, Japan
TEL	042-639-1111
Homepage URL
Email	kyamaguchi@tokai.ac.jp

Sponsor
Institute	Tokai University Hachioji Hospital
Institute
Department

Funding Source
Organization	Japanese Society of Allergology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokai University School of Medicine
Address	143 Shimokasuya, Isehara, Kanagawa, Japan
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.jp

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	2019 Year 08 Month 05 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	Preinitiation
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 31 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042796