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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
EU CTIS ID: 2024-513289-21-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.