EARLYEMOLLIENT - Feasibility of Early Emollient Use in Children With Atopic Eczema (EARLYemo)
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|ClinicalTrials.gov Identifier: NCT03376243|
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Other: LIPIKAR BAUME AP+ emollient||Not Applicable|
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.
The primary objectives are to investigate the
- Parental willingness to enter a child in a controlled primary prevention trial
- Compliance with intervention
- Safety: incidence of skin-related adverse events and serious adverse events during the study
- Cumulative incidence of AE within 2 years after randomization.
- Age of onset of AE
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 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.
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.
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.
The primary outcomes will be feasibility, safety and tolerability, and preventive effectiveness.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Willingness to participate [ Time Frame: 2 years ]Willingness of parents to get their child randomized and to adhere to the regimen
- Development of AE [ Time Frame: 2 years ]Cumulative incidence of AE
- Transepidermal water loss [ Time Frame: 2 years ]Development of transepidermal water loss over time
- Microbiome diversity [ Time Frame: 2 years ]Development of microbiome diversity over time
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
|Contact: Stephan Weidinger, Prof||+49 431500 ext firstname.lastname@example.org|
|Contact: Inken Harder||+49 431 500 ext email@example.com|
|Kiel, Scheswig-Holstein, Germany, 24105|
|Contact: Inken Harder +49 431 500 ext 21346 firstname.lastname@example.org|
|Principal Investigator:||Stephan Weidinger, Prof||University of Schleswig-Holstein|