Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT04398758
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
21 Days
Study:
NCT04398758
Study Brief:
Protocol Section:
NCT04398758