Clinical trial NCT04398758: Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood
Official title: 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 Application of a Moisturizing Barrier-stabilizing Skin Cream
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atopic Dermatitis
Infant, Newborn
Keywords: Skin care
Prevention
Risk factor
Interventional study
Multicentric
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2020-05-21
Enrollment: 360
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, non-treatment-controlled, investigator-blinded, multicenter, 2-arm parallel group study (main phase: from inclusion until 6 months of age with treatment group and control group (without treatment) according to 1:1 randomisation; follow-up phase: 6-12 months of age in which only half of the children from the treatment group is treated according to initial 1:1 randomisation)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of children with atopic dermatitis at 6 months of age
timeFrame: 0-6 months of age
Secondary outcomes:
measure: Cumulative incidence of children with atopic dermatitis at the age of 12 and 16 weeks and 9, 12 and 6-12 months
timeFrame: 0-12 months of age
measure: Cumulative incidence of children with preliminary diagnosis of atopic dermatitis (regardless of whether chronification is confirmed) at 12 and 16 weeks and 6, 9 and 12 months
timeFrame: 0-12 months of age
measure: Time to onset of atopic dermatitis at the age of 0-6, 6-12 and 0-12 months
timeFrame: 0-12 months of age
measure: Cumulative incidence and frequency of children with xerosis at the age of 6 and 12 months
timeFrame: 0-12 months of age
measure: Cumulative incidence and frequency of children with signs of itching at 6 and 12 months of age
timeFrame: 0-12 months of age
measure: Cumulative incidence and frequency of children with other types of eczema at 6 and 12 months of age
timeFrame: 0-12 months of age
measure: Severity of atopic dermatitis at the time of detection of (confirmed) atopic dermatitis up to the age of 12 and 16 weeks and 6, 9 and 12 months
timeFrame: 0-12 months of age
measure: 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
timeFrame: 0-12 months of age
measure: Adverse events: overall frequency, type, severity, causality, with frequencies, separate presentation of local reactions up to the age of 6 and 12 months
timeFrame: 0-12 months of age
measure: Drop-outs (with reasons) up to the age of 6 and 12 months
timeFrame: 0-12 months of age
measure: Compliance regarding the use of the investigational medicinal product in the treatment group up to the age of 6, 12 and 6-12 months
timeFrame: 0-12 months of age
measure: 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
timeFrame: 0-12 months of age
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Bauer, Gilb, von Bentzel
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel
city: Bochum
country: Germany
facility: Katholisches Klinikum Bochum gGmbH
city: Bonn
country: Germany
facility: St. Marien-Hospital
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Regensburg
country: Germany
facility: Barmherzige Brüder Klinik St. Hedwig
city: Tuttlingen
country: Germany
facility: Gemeinschaftspraxis für Kinder- und Jugendmedizin
city: Wesel
country: Germany
facility: Marien Hospital Wesel
Study officials:
affiliation: Charite University, Berlin, Germany
name: Kirsten Beyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: