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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03376243
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

T


Condition or disease Intervention/treatment
Atopic Dermatitis 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study to Determine the Feasibility of Early Emollient Use in Children With High Risk for Atopic Eczema - EARLYemollient
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Willingness to participate [ Time Frame: 2 years ]
    Willingness of parents to get their child randomized and to adhere to the regimen


Secondary Outcome Measures :
  1. Development of AE [ Time Frame: 2 years ]
    Cumulative incidence of AE

  2. Transepidermal water loss [ Time Frame: 2 years ]
    Development of transepidermal water loss over time

  3. Microbiome diversity [ Time Frame: 2 years ]
    Development of microbiome diversity over time


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376243


Contacts
Contact: Stephan Weidinger, Prof +49 431500 ext 21110 sweidinger@dermatology.uni-kiel.de
Contact: Inken Harder +49 431 500 ext 21346 iharder@dermatology.uni-kiel.de

Locations
Germany
USchleswig-Holstein Recruiting
Kiel, Scheswig-Holstein, Germany, 24105
Contact: Inken Harder    +49 431 500 ext 21346    iharder@dermatology.uni-kiel.de   
Sponsors and Collaborators
University of Schleswig-Holstein
Technische Universität Dresden
Investigators
Principal Investigator: Stephan Weidinger, Prof University of Schleswig-Holstein
More Information

Responsible Party: Prof. Dr. Stephan Weidinger, Deputy Head, Department of Dermatology and Allergy, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03376243     History of Changes
Other Study ID Numbers: Earlyemollient Version 2.0
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Stephan Weidinger, University of Schleswig-Holstein:
Atopic eczema, prevention

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Emollients
Dermatologic Agents