UMIN-CTR Clinical Trial

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
Email	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/
Email	allergy_research@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031912