UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of epicutaneous immunotherapy for severe egg allergy; Long term trial
Acronym	Epicutaneous immunotherapy for egg allergy
Scientific Title	Efficacy and safety of epicutaneous immunotherapy for severe egg allergy; Long term trial
Scientific Title:Acronym	Epicutaneous immunotherapy for egg 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	Change of dose threshold in oral egg challenge from 24 weeks to 48 weeks of treatment
Key secondary outcomes	1.Change of dose threshold in oral egg 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 5.Basophil activation test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Cutaneous application of ovomucoid-containing hydrogel patch 12 hours a day for 48 weeks
Interventions/Control_2	Outaneous application of ovomucoid-containing hydrogel patch 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	4 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Egg allergy diagnosed by oral food challenge (OFC) without tendency of natural outgrow 2) Cooked egg dose threshold of OFC =<2g and underwent cutaneous application of ovomucoid-containing hydrogel patch or hydrogel patch without containing antigen for 24 weeks. 3)Cooked egg dose threshold of OFC =<2g after intervetion of 2).
Key exclusion criteria	1) Allergy to soy and milk 2) Large change in intake levels of egg before 3 months of the trial 3) Complication or past history of heart, liver and kidney diseases 4) Uncontrolled asthma or atopic dermatitis
Target sample size	20

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

Public contact
Name of contact person	1st name Middle name Last name Yu Kuwabara
Organization	National Hospital Organization Mie National Hospital
Division name	Allergy center
Zip code
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	Nipponham Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	国立病院機構三重病院

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 23 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	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
Date of IRB	2016 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 26 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2019 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029194