Study on the prevention of atopic dermatitis symptoms in children with a high risk of the disease through the regular use of a moisturizing skin cream
Key facts
- Where
- Augsburg, Berlin, Berlin-Kreuzberg, Bielefeld, Bochum, Duesseldorf, Regensburg, Tuttlingen, Wesel és Wolfsburg, NémetországSee the 11 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum AugsburgAugsburg, NémetországNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Praxis für Kinder- und JugendmedizinBerlin-Kreuzberg, NémetországNo longer taking part
- Evangelisches Klinikum Bethel gGmbHBielefeld, NémetországNo longer taking part
- Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-HospitalBochum, NémetországNo longer taking part
- Evangelisches Krankenhaus DuesseldorfDuesseldorf, NémetországNo longer taking part
- Barmherzige Brueder, Klinik Sankt HedwigRegensburg, NémetországNo longer taking part
- Gemeinschaftspraxis für Kinder- und JugendmedizinTuttlingen, NémetországNo longer taking part
- Marien-Hospital Wesel gGmbHWesel, NémetországNo longer taking part
- Kinderaerztliche Gemeinschaftspraxis WolfsburgWolfsburg, NémetországNo longer taking part
- PediaMed WolfsburgWolfsburg, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Trial code
- EU 2024-513289-21-00
- Record updated
- 2026. március 17.
- Original description
The MOPAD study aims to evaluate the clinical efficacy of the SanaCutan Basiscreme by comparing the cumulative incidence of atopic dermatitis (AD) in infants with high familial risk between the treatment group and the control group (without treatment) at the age of 6 months. A clinical efficacy (primary objective) is achieved if the cumulative AD incidence in the treatment group at the age of 6 months is significantly lower than in the control group (p < 0.05). AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as “AD” in the context of the study (this does not refer to the initial detection of AD symptoms).Read full original descriptionShow less
Prospective, randomized, non-treatment controlled, investigator-blinded, multicenter study on the prophylaxis of early childhood symptoms of atopic dermatitis in high-risk children by continuous continuous application of a moisturizing barrier-stabilizing skin cream
The MOPAD study aims to evaluate the clinical efficacy of the SanaCutan Basiscreme by comparing the cumulative incidence of atopic dermatitis (AD) in infants with high familial risk between the treatment group and the control group (without treatment) at the age of 6 months. A clinical efficacy (primary objective) is achieved if the cumulative AD incidence in the treatment group at the age of 6 months is significantly lower than in the control group (p < 0.05). AD is confirmed if in at least 2 examinations at an interval of at least 4 weeks (initial diagnosis + evidence of chronification) an AD is diagnosed. A confirmed AD is abbreviated as “AD” in the context of the study (this does not refer to the initial detection of AD symptoms).
Inclusion: Healthy newborns (male or female); Age < 3 weeks (≤ 21st day of life); High familial risk of atopic dermatitis with at least one 1st degree relative (parent or sibling) with a history of medically diagnosed atopic dermatitis; Written declaration of consent from all legal guardians.
Exclusion: Known alcohol, medication or drug addiction of the guardians; Previous participation in another clinical trial (since birth); Previous participation in this study; Corticosteroid or calcineurin inhibitor use or taking cyclosporine; Acute or chronic diseases; Serious genetic skin diseases or skin conditions that make the use of skin creams unsuitable; Known hypersensitivity to any of the ingredients of SanaCutan Basiscreme; Limited legal capacity of the guardians; Inability of the guardians to understand the study instructions; Obvious unreliability or lack of cooperation of the guardians; Dependence of the child or guardian on the sponsor or investigator; Acute fever (> 38.5 °C); Serious congenital malformations; Hydrops fetalis; Immunodeficiency (of any kind); Prematurity (< 37 weeks).