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
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 28, 2021
September 1, 2021
3.6 years
December 6, 2017
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Willingness to participate
Willingness of parents to get their child randomized and to adhere to the regimen
2 years
Secondary Outcomes (3)
Development of AE
2 years
Transepidermal water loss
2 years
Microbiome diversity
2 years
Study Arms (2)
Emollient (LIPIKAR BAUME AP+)
EXPERIMENTALDaily application of Lipikar Baume AP+ emollient AND Structured parent education
Control
NO INTERVENTIONOnly structured parent education
Interventions
Structured education on prevention guidelines
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USchleswig-Holstein
Kiel, Scheswig-Holstein, 24105, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Weidinger, Prof
University Hospital Schleswig-Holstein
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Head, Department of Dermatology and Allergy
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 18, 2017
Study Start
February 1, 2017
Primary Completion
September 1, 2020
Study Completion
June 1, 2021
Last Updated
September 28, 2021
Record last verified: 2021-09