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
- Conditions
- Children with a high risk of developing atopic dermatitis
- Registration Number
- 2024-513289-21-00
- Lead Sponsor
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 360
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
Acute or chronic diseases
Limited 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, medication or drug addiction of the guardians
Dependence of the child or guardian on the sponsor or investigator
Previous participation in another clinical trial (since birth)
Previous participation in this study
Acute fever (> 38.5 °C)
Serious congenital malformations
Hydrops fetalis
Immunodeficiency (of any kind)
Serious genetic skin diseases or skin conditions that make the use of skin creams unsuitable
Corticosteroid or calcineurin inhibitor use or taking cyclosporine
Prematurity (< 37 weeks)
Known hypersensitivity to any of the ingredients of SanaCutan Basiscreme
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. 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). The primary end point is defined as the cumulative incidence of atopic dermatitis (AD) at the age of 6 months. 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).
- Secondary Outcome Measures
Name Time Method Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months Compliance regarding the use of other skin care products (not investigational medicinal product) in both groups up to the age of 6, 12 and 6-12 months
Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months Cumulative incidence of children with AD at 12 and 16 weeks, 9, 12 and 6-12 months
Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed at 12 and 16 weeks, 6, 9 and 12 months of age
Time to onset of AD at 0-6, 6-12 and 0-12 months of age Time to onset of AD at 0-6, 6-12 and 0-12 months of age
Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age Cumulative incidence and frequency of children with xerosis at 6 and 12 months of age
Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age Cumulative incidence and frequency of children with eczema of other types at 6 and 12 months of age
Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age Severity of AD at the time of detection of (confirmed) AD up to 12 and 16 weeks and 6, 9 and 12 months of age
Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months Frequency of sensitization to food allergens (according to Fx5 test + hazelnut) and to inhalation allergens (according to Sx1 test) and total IgE at the age of 6, 9 and 12 months
Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to 6 and 12 months of age
Drop-outs (with reasons) up to 6 and 12 months of age Drop-outs (with reasons) up to 6 and 12 months of age
Trial Locations
- Locations (11)
Universitaetsklinikum Augsburg
🇩🇪Augsburg, Germany
Gemeinschaftspraxis für Kinder- und Jugendmedizin
🇩🇪Tuttlingen, Germany
Charite Universitaetsmedizin Berlin KöR
🇩🇪Berlin, Germany
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
🇩🇪Bochum, Germany
Praxis für Kinder- und Jugendmedizin
🇩🇪Berlin-Kreuzberg, Germany
Kinderaerztliche Gemeinschaftspraxis Wolfsburg
🇩🇪Wolfsburg, Germany
Barmherzige Brueder, Klinik Sankt Hedwig
🇩🇪Regensburg, Germany
Evangelisches Krankenhaus Duesseldorf
🇩🇪Duesseldorf, Germany
PediaMed Wolfsburg
🇩🇪Wolfsburg, Germany
Evangelisches Klinikum Bethel gGmbH
🇩🇪Bielefeld, Germany
Scroll for more (1 remaining)Universitaetsklinikum Augsburg🇩🇪Augsburg, GermanyMichael GerstlauerSite contact+498214009218Michael.Gerstlauer@uk-augsburg.de