Early Aggressive Intervention for Infantile Atopic Dermatitis to Prevent Development of Food Allergy: a Multicenter, Investigator-Blinded, Randomized, Parallel Group Controlled Trial

Not Applicable

• Conditions: Atopic Dermatitis

• Registration Number: JPRN-UMIN000028043
• Lead Sponsor: ational Center for Child Health and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-04
• Study Completion: 2021-02-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of oral food challenge-proven IgE-mediated hen egg allergy at 28 weeks of age

Secondary Outcome Measures

Name	Time	Method
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