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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- INFECTOPHARM Arzneimittel und Consilium GmbH
- Enrollment
- 360
- Locations
- 11
- Primary Endpoint
- 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).
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
InfectoPharm
Scientific
INFECTOPHARM Arzneimittel und Consilium GmbH
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
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 Outcomes
- 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
- 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
- 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 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
- 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
- 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