UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037562 |
|---|---|
| Receipt number | R000042796 |
| Scientific Title | Efficacy of the epicutaneous immunotherapy for food allergy -Selection of skin sticking device and allergen- |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2019/07/31 18:08:55 |
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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
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
kyamaguchi@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hachioji Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042796
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
