Early Intervention with Difamilast Ointment in infantile Early-Onset Atopic dermatitis for Prevention of Transcutaneous Sensitization (DIFENSE Study)
DIFENSE Study
Yamamoto-Hanada Kiwako
National Center for Child Health and Development
2-10-1 Okura,Setagaya-ku,Tokyo
+81-334160181
yamamoto-k@ncchd.go.jp
Yamamoto-Hanada Kiwako
National Center for Child Health and Development
2-10-1 Okura,Setagaya-ku,Tokyo
+81-3-3415-9260
allergy_research@ncchd.go.jp
Recruiting
Feb. 15, 2025
May. 01, 2025
150
Interventional
randomized controlled trial
open(masking not used)
active control
parallel assignment
prevention purpose
(1) Infants 42 to 90 days of age at the obtaining of consent
(2) Infants diagnosed with atopic dermatitis based on The U.K. Working Party's diagnostic criteria within 28 days of the appearance of an itchy skin eruption at the time of consent
(3) Infants with a skin eruption (including dryness) of more than slight severity on the whole body except for the scalp, based on the severity of skin eruption described in the Atopic Dermatitis Clinical Practice Guidelines 2021 at the time of registration.
(1) Infants born at less than 37 weeks of gestation.
(2) Infants with a history of adverse effects caused by the drugs used in this study.
(3) Infants with a history of prior application of Difamilast ointment before registration.
(4) Infants with a history of IgE-dependent egg allergy at the time of registration.
(5) Infants with the possibility of not being able to visit the medical institution by 16 weeks after enrollment due to plans to move to a new address, etc.
(6) Infants whose proxy cannot understand the study content in Japanese.
(7) Infants whose consent for this study cannot be obtained from the proxy.
(8) Infants with a severe underlying condition or a skin condition that may affect the evaluation of atopic dermatitis and deemed unsuitable for participation by the principal investigator, responsible investigator, or participating investigator.
(9) Hemorrhagic blood diseases (hemophilia, thrombocytopenia, purpura, etc.) that are contraindications to Heparinoid ointment.
(10) Infants who were receiving prohibited concomitant medications from the screening to registration.
0age 1month old over
0age 3month old not
Both
Atopic Dermatitis
Difamilast Treatment Group
Early intervention remission maintenance therapy with topical PDE4 inhibitor
-Full Body except scalp: Moizert ointment 0.3%, 1.0% twice daily. Apply an appropriate amount of the 0.3% formulation twice daily to all parts of the body except the scalp, which is the affected area. According to the judgment of the principal investigator or sub-investigator, a 1.0% formulation to be applied to the full body except scalp twice daily in an appropriate amount depending on the symptoms. If symptoms improve with the 1% formulation, consider switching to the 0.3% formulation by principal investigator or sub-investigator.
-Mild or more severe skin lesions: topical steroids (reactive therapy)
Standard Treatment Group
Early intervention remission maintenance therapy with conventional therapy
-Full Body except scalp: Hirudoid Soft Ointment 0.3%, twice daily
-Mild or more severe skin lesions: topical steroids (reactive therapy)
Dermatitis,Atopic, Eczema,Immunoglobulin E, food hypersensitivity, secondary prevention
Percentage sensitized to serum egg white/ovomucoid/milk/wheat/omega-5 gliadin/walnut/Jug r 1/peanut/Ara h 2 at 16 weeks post-registration
(1) Percentage of sensitization to serum egg white/omega-5 gliadin/milk/wheat/peanut/Ara h2/walnut/Jug r 1 IgE at 16 weeks post-registration measured by ImmunoCAP
(2) EASI (Eczema Area and Severity Index) scores at 4, 8, and 16 weeks post-registration
(3) POEM (Patient-Oriented Eczema Measure) scores during the study period
(4) Percentage of days of remission from atopic dermatitis during the study period
(5) Percentage of additional treatment implementation
(6) Percentage of occurrence of serious adverse events during the treatment period
Otsuka Pharmaceutical Co.,Ltd
Applicable
Japan Agency for Medical Research and Development
Applicable
Certified Review Board of National Center for Child Health and Development
