Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood (MOPAD)

InfectoPharm

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis; Infant, Newborn

Treatments: Drug: SanaCutan Basiscreme

Study type: Interventional

Funder types: Industry

Identifiers

NCT04398758

2018-004762-33 (EudraCT Number)

MOPAD

Details and patient eligibility

About

In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.

Full description

Enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. The treatment group receives the SanaCutan Basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. Guardians of both groups are requested to document all applied skin care products in a diary. In regular visits at the study sites, a blinded physician investigates the skin of the children. In case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (SCORAD) and the treatment with SanaCutan Basiscreme will be terminated. All children will be followed up until the age of 6 months (end of main phase). This is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total IgE. If children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).

Enrollment: 360 estimated patients

Sex: All

Ages: Under 21 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy newborns (male or female)
• Age < 3 weeks (≤ 21st day of life)
• High familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history
• Written consent of all guardians

Exclusion criteria

• Acute or chronic diseases
• Acute fever (> 38.5 °C)
• Severe congenital malformations
• Hydrops fetalis
• Immunodeficiency (any kind)
• Severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable
• Corticoid or calcineurin inhibitor use or Ciclosporin intake
• Preterm birth (< 37 weeks)
• Known hypersensitivity to one of the ingredients of the SanaCutan Basiscreme
• Restricted 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, medicine or drug dependency of the guardians
• Dependence of the child or guardians on the sponsor or the investigator
• Previous participation in another clinical trial (since birth)
• Previous participation in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Treatment group

Experimental group

Description:

Children of the treatment group receive the cream "SanaCutan Basiscreme". The cream's main ingredients are white soft paraffin and liquid paraffin and it is already approved for the treatment of several skin diseases due to its skin care effect.

Treatment:

Drug: SanaCutan Basiscreme

Control group

No Intervention group

Description:

Children of the control group should avoid regular skincare applications. Skincare is not prohibited, however, it is recommended to use products only in urgent cases.