2024-513289-21-00CompletedPhase 3
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 17 Sept 2024
- Start date
- 13 Jan 2020
- Lead sponsor
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Diseases
- Atopic dermatitis (eczema)
- EU CT number
- 2024-513289-21-00
- EudraCT number
- 2018-004762-33
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 360
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: - to 17 years · Sex: All · Accepts healthy volunteers
Sites (11)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Augsburg | Augsburg | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Completed |
| Praxis für Kinder- und Jugendmedizin | Berlin-Kreuzberg | Germany | Completed |
| Evangelisches Klinikum Bethel gGmbH | Bielefeld | Germany | Completed |
| Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital | Bochum | Germany | Completed |
| Evangelisches Krankenhaus Duesseldorf | Duesseldorf | Germany | Completed |
| Barmherzige Brueder, Klinik Sankt Hedwig | Regensburg | Germany | Completed |
| Gemeinschaftspraxis für Kinder- und Jugendmedizin | Tuttlingen | Germany | Completed |
| Marien-Hospital Wesel gGmbH | Wesel | Germany | Completed |
| Kinderaerztliche Gemeinschaftspraxis Wolfsburg | Wolfsburg | Germany | Completed |
| PediaMed Wolfsburg | Wolfsburg | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.