Last updated: June 23, 2022
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Recruiting
Phase
3
Condition
Atopic Dermatitis
Dermatitis, Atopic
Hives (Urticaria)
Treatment
N/AClinical Study ID
NCT04398758
MOPAD
2018-004762-33
Ages < 21 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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-degreerelative (parent or sibling) with a medically diagnosed atopic dermatitis in themedical history
- Written consent of all guardians
Exclusion
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 creamsunsuitable
- 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
Study Design
Total Participants: 360
Study Start date:
July 22, 2020
Estimated Completion Date:
June 30, 2024
Study Description
Connect with a study center
Gemeinschaftspraxis Bauer, Gilb, von Bentzel
Augsburg, 86150
GermanySite Not Available
Universitätsklinikum Augsburg
Augsburg, 86156
GermanyActive - Recruiting
Charité Universitätsmedizin
Berlin, 13353
GermanyActive - Recruiting
Evangelisches Klinikum Bethel
Bielefeld, 33617
GermanyActive - Recruiting
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
GermanySite Not Available
St. Marien-Hospital
Bonn, 53115
GermanySite Not Available
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
GermanyActive - Recruiting
Barmherzige Brüder Klinik St. Hedwig
Regensburg, 93049
GermanyActive - Recruiting
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Tuttlingen, 78532
GermanyActive - Recruiting
Marien Hospital Wesel
Wesel, 46483
GermanyActive - Recruiting
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