UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027459 |
|---|---|
| Receipt number | R000031448 |
| Scientific Title | Efficacy and safety of epicutaneous immunotherapy for severe milk allergy; Long term trial |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2020/08/27 09:11:32 |
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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
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
yu_surrealist@hotmail.co.jp
Sponsor or person
Institute
National Hospital Organization Mie National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031448
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