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

NCT ID: NCT03376243

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2021-06-01

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Emollient (LIPIKAR BAUME AP+)

Daily application of Lipikar Baume AP+ emollient AND Structured parent education

Group Type: EXPERIMENTAL

LIPIKAR BAUME AP+ emollient

Intervention Type: OTHER

Structured education on prevention guidelines

Control

Only structured parent education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LIPIKAR BAUME AP+ emollient

Structured education on prevention guidelines

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Stephan Weidinger

Deputy Head, Department of Dermatology and Allergy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan Weidinger, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

USchleswig-Holstein

Kiel, Scheswig-Holstein, Germany

Countries

Germany

Other Identifiers

Earlyemollient Version 2.0

Identifier Type: -

Identifier Source: org_study_id