Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

  • STATUS
    Recruiting
  • participants needed
    360
  • sponsor
    Infectopharm Arzneimittel GmbH
Updated on 19 February 2024
atopy
dermatitis

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 1years or below
Treatment SanaCutan Basiscreme
Clinical Study IdentifierNCT04398758
SponsorInfectopharm Arzneimittel GmbH
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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