Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Infectopharm Arzneimittel GmbH
• Collaborator: Gesellschaft für Therapieforschung mbH

Criteria

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