Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

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 Application of a Moisturizing Barrier-stabilizing Skin Cream

In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.

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).

Inclusion Criteria:

• Healthy newborns (male or female)
• Age < 3 weeks (≤ 21st day of life)
• High familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history
• Written consent of all guardians

Exclusion Criteria:

• Acute or chronic diseases
• Acute fever (> 38.5 °C)
• Severe congenital malformations
• Hydrops fetalis
• Immunodeficiency (any kind)
• Severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable
• Corticoid or calcineurin inhibitor use or Ciclosporin intake
• Preterm birth (< 37 weeks)
• Known hypersensitivity to one of the ingredients of the SanaCutan Basiscreme
• Restricted legal capacity of the guardians
• Inability of the guardians to understand the study instructions
• Obvious unreliability or lack of cooperation of the guardians
• Known alcohol, medicine or drug dependency of the guardians
• Dependence of the child or guardians on the sponsor or the investigator
• Previous participation in another clinical trial (since birth)
• Previous participation in this study