UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025381 |
|---|---|
| Receipt number | R000029194 |
| Scientific Title | Efficacy and safety of epicutaneous immunotherapy for severe egg allergy; Long term trial |
| Date of disclosure of the study information | 2016/12/23 |
| Last modified on | 2019/12/25 23:09:38 |
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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
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
yu_surrealist@hotmail.co.jp
Sponsor or person
Institute
National Hospital Organization Mie National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029194
