UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028043 |
|---|---|
| Receipt number | R000031912 |
| Scientific Title | Early Aggressive Intervention for Infantile Atopic Dermatitis to Prevent Development of Food Allergy: a Multicenter, Investigator-Blinded, Randomized, Parallel Group Controlled Trial |
| Date of disclosure of the study information | 2017/07/04 |
| Last modified on | 2022/02/13 15:53:47 |
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Basic information
Public title
Early Aggressive Intervention for Infantile Atopic Dermatitis to Prevent Development of Food Allergy: a Multicenter, Investigator-Blinded, Randomized, Parallel Group Controlled Trial
Acronym
Prevention of Allergy via Cutaneous Intervention (PACI) Study
Scientific Title
Early Aggressive Intervention for Infantile Atopic Dermatitis to Prevent Development of Food Allergy: a Multicenter, Investigator-Blinded, Randomized, Parallel Group Controlled Trial
Scientific Title:Acronym
Prevention of Allergy via Cutaneous Intervention (PACI) Study
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the superiority of the early aggressive treatment over the standard treatment with a randomized controlled trial for infantile atopic dermatitis to prevent food allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of oral food challenge-proven IgE-mediated hen egg allergy at 28 weeks of age
Key secondary outcomes
1. Symptom score of Food challenge test at 28 weeks of age
2. Total IgE antibody serum titer at 28 weeks of age
3. Egg white, ovomucoid, milk, wheat, soy, peanut and Ara h2-specific IgE antibody serum titer at 28 weeks of age
4. Egg white, ovomucoid, milk, wheat, soy, peanut and Ara h2-specific IgG4 antibody serum titer at 28 weeks of age
5. EASI scores at 2, 4, and 8 weeks after study entry and at 28 weeks of age
6. POEM scores during the study period
7. Proportion of disease free days during the study period
8. Dose of rescue medication used during the study period
9. IDQoL at 28 weeks of age
10. DFI at 28 weeks of age
11. Presence of IgE-mediated food allergy reaction during the study
12. Presence of wheezing during the study period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
A:Aggressive treatment group: Early aggressive treatment with topical anti-inflammatory drug (proactive method)
Interventions/Control_2
B:Standard treatment group: Standard treatment based on the Guidelines for the Management of Atopic Dermatitis (2016) (reactive method)
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
| 7 | weeks-old | <= |
Age-upper limit
| 13 | weeks-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants (7-13 weeks old) who develop an itchy rash within the previous 28 days and are diagnosed with Atopic Dermatitis based on the U.K.Working Party's diagnostic criteria
Key exclusion criteria
(1)Infants born before 37 weeks of gestation
(2)Twin or multiple
(3)History of side effects from emollients (Heparinoid cream :Hirudoid Soft ointment) and/or topical corticosteroids (alclometasone dipropionate :Almeta, betamethasone valerate :Rinderon-V and/or mometasone furoate :Fulumeta).
(4)History of taking oral and/or intravenous steroids within the previous 28 days
(5)History of taking immunosuppressive agents (ciclosporin, tacrolimus, etc) and/or biologics except immunizations and/or intravenous immunoglobulin within the previous 28 days.
(6)IgE-mediated hen egg allergy
(7)Infants whose family plans to move and who may not be able to visit the study site before 28 weeks of age
(8)Parents unable to understand Japanese
(9)Unwillingness or inability to comply with the study requirements and procedures
(10)Infants with severe congenital disease and/or a disease that affects dermatological evaluation
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Ohya |
Organization
National Center for Child Health and
Development
Division name
Allergy Center
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
03-3416-0181
ohya-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kiwako |
| Middle name | |
| Last name | Yamamoto-Hanada |
Organization
PACI Study Coordinating Office
Division name
Allergy Center, National Center for Child Health and Development
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
03-3416-0611
Homepage URL
http://www.paci-study.jp/
allergy_research@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of the National Center for Child Health and Development
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
Tel
03-3416-0181
rinri@ncchd.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
国立成育医療研究センター（東京都）
浜松医科大学医学部附属病院 (静岡県）
国立病院機構名古屋医療センター（愛知県）
国立病院機構三重病院（三重県）
国立病院機構相模原病院（神奈川県）
京都府立医科大学附属病院（京都府）
大阪府立病院機構大阪はびきの医療センター（大阪府）
藤田保健衛生大学病院（愛知県）
山口大学医学部附属病院（山口県）
慶應義塾大学病院（東京都）
公立昭和病院（東京都）
千葉大学医学部附属病院（千葉県）
近畿大学医学部附属病院（大阪府）
藤田保健衛生大学坂文種報德會病院（愛知県）
さいたま市立病院（埼玉県）
東北医科薬科大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
https://ctajournal.biomedcentral.com/articles/10.1186/s13601-018-0233-8
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
650
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
| 2017 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 10 | Month | 08 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031912
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| Registered date | File name |
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