UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of epicutaneous immunotherapy for severe milk allergy; Long term trial
Acronym	Epicutaneous immunotherapy for milk allergy
Scientific Title	Efficacy and safety of epicutaneous immunotherapy for severe milk allergy; Long term trial
Scientific Title:Acronym	Epicutaneous immunotherapy for milk allergy
Region	Japan

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

Objectives
Narrative objectives1	Oral immunotherapy has been shown to have some efficacy in inducing desensitization for patients with severe unremitting food allergy. However, limitation has also been shown in terms of its side effects and difficulty in inducing tolerance. Safer and more effective therapy is needed. In this study, we aim to investigate efficacy and safety of an epicutaneous immunotherapy by using a novel transcutaneous antigen delivery device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Proportion of the subjects who tolerate more than 3 ml of milk (total dose) at oral milk challenge after the treatment for 48 weeks
Key secondary outcomes	1.Change of dose threshold in oral milk challenge after 24 weeks of treatment 2.Safety:local reaction,systemic immediate-type allergic reaction and other 3.Prick test 4.Specific IgE and IgG4

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Cutaneous application of hydrogel patch containing cow's milk concentrate for 12 hours a day for 48 weeks
Interventions/Control_2	Cutaneous application of hydrogel patch containing cow's milk concentrate for 12 hours a day for 24 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	2 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Milk allergy diagnosed by oral food challenge (OFC) without tendency of natural outgrow 2) Milk dose threshold of OFC =<3ml(total dose) and underwent cutaneous application of cow's milk concentrate-containing hydrogel patch or hydrogel patch without containing antigen for 24 weeks. 3)Milk dose threshold of OFC =<3ml(total dose) after intervetion of 2).
Key exclusion criteria	1)patients who have heart, liver and kidney diseases 2)patients with ncontrolled asthma or atopic dermatitis
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Fujisawa
Organization	National Hospital Organization Mie National Hospital
Division name	Allergy center
Zip code	514-0125
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	+81592322531
Email	fujisawa@mie-m.hosp.go.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Kuwabara
Organization	National Hospital Organization Mie National Hospital
Division name	Allergy center
Zip code	514-0125
Address	357 Osato-kubota, Tsu, Mie, Japan
TEL	+81592322531
Homepage URL
Email	yu_surrealist@hotmail.co.jp

Sponsor
Institute	National Hospital Organization Mie National Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Ethics Committees of Mie National Hospital.
Address	357 Osato-kubota, Tsu, Mie, Japan
Tel	+81592322531
Email	fujisawa@mie-m.hosp.go.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	国立病院機構三重病院、国立病院機構相模原病院、福井大学病院、群馬大学病院、獨協医大病院、千葉大学病院、、国立病院機構下志津病院、、千葉県子ども病院、富山大学病院、あいち小児保健医療総合センター、大阪府立呼吸器アレルギー医療センター

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 29 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	46
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Due to organizing data and performing additional analysis.
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	2017 Year 05 Month 15 Day
Date of IRB	2017 Year 05 Month 22 Day
Anticipated trial start date	2017 Year 05 Month 29 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2020 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031448