PACI Study—protocol for a randomized controlled trial >>
EXPECTATION FOR EARLY AGGRESSIVE INTERVENTION FOR ATOPIC DERMATITS
Allergic march refers to the natural history or typical progression of allergic diseases that often begin early in life. These include atopic dermatitis (eczema), food allergy, allergic rhinitis (hay fever), and asthma. In most patients, atopic dermatitis is the first clinical manifestation with the highest incidence in the first year of life and those affected develop other allergic diseases such as food allergy, asthma, and allergic rhinitis later in childhood. To prevent future allergic march, an appropriate intervention for atopic dermatitis, which emerges on the first stage of allergic march, is important to be considered. There is a possibility that early aggressive intervention for atopic dermatitis may normalize the function of the skin barrier and reduce allergy sensitization through the skin. If infants with atopic dermatitis can be protected from allergen exposures and skin inflammation, this will likely prevent development of later allergen sensitization, food allergy, asthma, and allergic rhinitis.
NECESSITY AND SIGNIFICANCE OF THE STUDY
Infants who develop to atopic dermatitis in early infancy have a high risk of developing food allergy. The increasing prevalence of food allergy is a current worldwide epidemic that is resulting in an increased risk of life-threating anaphylaxes. Clinicians and researchers are working to reverse this trend. This is the first study to examine the efficacy and safety of early aggressive intervention for atopic dermatitis compared to standard treatment based on the guidelines. The results from this study will be expected to reduce the prevalence of food allergy and medical costs if we can establish that this novel method of early aggressive intervention for atopic dermatitis prevents food allergy. In addition, the results from the study are expected to add important evidence that will be cited in government policy for overcoming allergic diseases because the Japanese government has implemented the Basic Law on Measures against Allergic Diseases in 2014. This study represents the turning point in the allergy epidemic that has emerged in the last century.
PURPOSE
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.
STUDY DESIGN
This study is designed as a multicenter, investigator-blinded, randomized, parallel group controlled trial.
STUDY SCHEME
PRIMARY OUTOME
Presence of oral food challrenge-proven IgE-mediated hen egg allergy at 28 weeks of age.
lRB Approval
IRB of National Center for Child Health and Development（No.1347）
TRIAL REGISTRATION
UMIN-CTR（UMIN000028043）
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031912
FUNDING SOURCE
The Japan Agency for Medical Research and Development（AMED）
PRINCIPAL INVESTIGATOR
Yukihiro OHYA, MD, PhD
Chief Physician - Division of Allergy, Department of Medical Specialties
National Center for Child Health and Development
2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan
Tel: +81-3-3416-0181; Fax: +81-3-3415-9260
CONTACT INFORMATION
Study Coordinating Center: Division of General Allergy, Allergy Center,
National Center for Child Health and Development
2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan
Phone: +81-3-3416-0611; Fax: +81-3-3415-9260
E-mail:allergy_research@ncchd.go.jp
