Atopic Dermatitis
Conditions
Interventions
A:Aggressive treatment group: Early aggressive treatment with topical anti-inflammatory drug (proactive method)
B:Standard treatment group: Standard treatment based on the Guidelines for the Managem
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of oral food challenge-proven IgE-mediated hen egg allergy at 28 weeks of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKiwako Yamamoto-Hanada
PACI Study Coordinating Office Allergy Center, National Center for Child Health and Development
Outcome results
None listed