Status:
UNKNOWN
Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Collaborating Sponsors:
Gesellschaft für Therapieforschung mbH
Conditions:
Atopic Dermatitis
Infant, Newborn
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief 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 Basiscre...
Detailed 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 appli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04398758
Start Date
July 22 2020
End Date
June 1 2024
Last Update
June 24 2022
Active Locations (10)
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1
Gemeinschaftspraxis Bauer, Gilb, von Bentzel
Augsburg, Germany, 86150
2
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
3
Charité Universitätsmedizin
Berlin, Germany, 13353
4
Evangelisches Klinikum Bethel
Bielefeld, Germany, 33617