EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema (EARLYemo)

A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient

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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Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: LIPIKAR BAUME AP+ emollient

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Scheswig-Holstein
    • Kiel, Scheswig-Holstein, Germany, 24105
      • USchleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Emollient (LIPIKAR BAUME AP+); Daily application of Lipikar Baume AP+ emollient AND Structured parent education	Other: LIPIKAR BAUME AP+ emollient; Structured education on prevention guidelines
NO_INTERVENTION: Control; Only structured parent education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Willingness to participate	Willingness of parents to get their child randomized and to adhere to the regimen	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of AE	Cumulative incidence of AE	2 years
Transepidermal water loss	Development of transepidermal water loss over time	2 years
Microbiome diversity	Development of microbiome diversity over time	2 years

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Technische Universität Dresden
• Investigators: Principal Investigator: Stephan Weidinger, Prof, University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): June 1, 2021

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Atopic eczema, prevention
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Dermatologic Agents; Emollients
• Other Study ID Numbers: Earlyemollient Version 2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No