Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
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- STATUS
- Recruiting
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- participants needed
- 360
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- sponsor
- Infectopharm Arzneimittel GmbH
Summary
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.
Description
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).
Details
| Condition | ATOPIC DERMATITIS, eczema (atopic dermatitis), ATOPIC DERMATITIS, dermatitis, atopic, Dermatitis, hand dermatitis, Neonate, dermatitis, atopic |
|---|---|
| Age | 1 years and younger |
| Treatment | SanaCutan Basiscreme |
| Clinical Study Identifier | NCT04398758 |
| Sponsor | Infectopharm Arzneimittel GmbH |
| Last Modified on | 19 February 2024 |
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