Clinical trial NCT03376243: EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema
Official title: A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic eczema, prevention
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
First posted: 2017-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this pragmatic, parallel group, assessor-blind randomised open-label prospective study is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of atopic eczema (AE). Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in newborns at high risk is safe and efficient in preventing AE.

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Detailed description: The aim of this trial is to determine the reasons that motivate parents to enrol or not enrol their child in a randomized, controlled basic emollient trial for the prevention of AE. Furthermore, this trial intends to test the hypothesis that daily skin barrier enhancement with Lipikar Baume AP+® in babies at high risk of allergic disease is safe and to estimate the preventive effectiveness of Lipikar Baume AP+® in the prevention of AE in a high risk population.

Objectives:

The primary objectives are to investigate the

1. Feasibility:

   1. Parental willingness to enter a child in a controlled primary prevention trial
   2. Compliance with intervention
2. Safety: incidence of skin-related adverse events and serious adverse events during the study
3. Effectiveness:

   1. Cumulative incidence of AE within 2 years after randomization.
   2. Age of onset of AE

Study design:

Pragmatic, parallel group, assessor-blind randomised open-label prospective study of emollient use in 50 high-risk neonates starting between days 1 and 21. Child participation in the main part of the trial will be 2 years (from within 3 weeks of birth until approximately the child's second birthday). This will comprise a 1 year intervention phase then the primary outcome is assessed at 2 years.

Participants:

Participants will be newborn babies at high risk of developing AE defined as a parent or sibling who has (or had) doctor diagnosed asthma, AE or allergic rhinitis.

Intervention:

The intervention is daily application of emollient to the baby's entire body surface area including the face for the first year of life. Intervention and control group will receive structured parent education that comprises general advice on best practice skin care for their baby in line with the German AWMF S3 guidelines for allergy prevention and the Federal Centre for Health Education.

Data collection:

Infants will be examined at scheduled visits at Months 1, 6, 12, and 24. Telephone visits were performed at months 3 and 18 to assess for side effects, rashes, and compliance. Daily parental recordings will be assessed using electronic data capturing tools.

Primary Outcomes:

The primary outcomes will be feasibility, safety and tolerability, and preventive effectiveness.

Eligibility criteria: Inclusion Criteria:

* Participant (i.e. the newborn baby) must have a parent or sibling with a history of AE, allergic rhinitis or asthma.
* Infant in overall good health.
* Term-born babies
* Mother at least 18 years of age at delivery and capable of giving informed consent.

Exclusion Criteria:

* Preterm birth (defined as birth prior to 37 weeks gestation).
* Previous child randomised to this trial.
* Major congenital anomaly.
* Significant inflammatory skin disease at birth (except seborrheic dermatitis).
* Any immunodeficiency disorder or severe genetic skin disorder.
* Any condition that would make the use of emollients inadvisable or not possible.

Primary outcomes:
measure: Willingness to participate
timeFrame: 2 years
Secondary outcomes:
measure: Development of AE
timeFrame: 2 years
measure: Transepidermal water loss
timeFrame: 2 years
measure: Microbiome diversity
timeFrame: 2 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: USchleswig-Holstein
state: Scheswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Stephan Weidinger, Prof
role: PRINCIPAL_INVESTIGATOR
References: