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Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

Recruiting
1 years and younger
All
Phase 3

Enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. The treatment group receives the SanaCutan Basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. Guardians of both groups are requested to document all applied skin care products in a diary. In regular visits at the study sites, a blinded physician investigates the skin of the children. In case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (SCORAD) and the treatment with SanaCutan Basiscreme will be terminated. All children will be followed up until the age of 6 months (end of main phase). This is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total IgE. If children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).

Study details
    ATOPIC DERMATITIS
    eczema (atopic dermatitis)
    ATOPIC DERMATITIS
    dermatitis
    atopic
    Dermatitis
    hand dermatitis
    Neonate
    dermatitis
    atopic

NCT04398758

Infectopharm Arzneimittel GmbH

19 February 2024

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