Prospective, randomized, non-treatment controlled, investigator-blinded, multicenter study on the prophylaxis of early childhood symptoms of atopic dermatitis in high-risk children by continuous continuous application of a moisturizing barrier-stabilizing skin cream

Children with a high risk of developing atopic dermatitis

The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as "AD" in the context of the study (this does not refer to the initial detection of AD symptoms).

Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months, Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age, Time to onset of AD at 0-6, 6-12 and 0-12 months of age, Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age, Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age, Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age, Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age, Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months, Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age, Drop-outs (with reasons) up to 6 and 12 months of age, Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months, Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months

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