Barrier Enhancement for Eczema Prevention
BEEP
A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.
1 other identifier
interventional
1,394
1 country
16
Brief Summary
The primary objective is to determine whether advising parents to apply emollient (moisturiser) to their child's skin for the first year of life in addition to best practice infant skin care advice can prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedNovember 28, 2022
November 1, 2022
4.1 years
December 8, 2015
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
A diagnosis of eczema between 12 and 24 months of age (defined as meeting the United Kingdom (UK) Working Party Diagnostic Criteria for Atopic Dermatitis).
To reflect the chronicity of eczema, these criteria refer to signs and symptoms present over the past year. Applying the criteria at 24 months of age will therefore detect eczema present only between the ages of 12 and 24 months, thus excluding transient eczematous rashes which are common in the first year of life and often reported by parents as "eczema" but less likely to be true atopic eczema
24 months
Secondary Outcomes (9)
Presence of parental report of eczema between birth and 24 months.
Up to 24 months
Presence of visible eczema at 24 months (skin examination by researcher).
24 months
Time to onset of eczema
24 months
Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis
Upto 24 months
Child health-related quality adjusted life years.
Upto 24 months
- +4 more secondary outcomes
Other Outcomes (15)
Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema
36, 48 and 60 months
Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months
3, 6, 12, 24, 36, 48 and 60 months
Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis
36, 48 and 60 months
- +12 more other outcomes
Study Arms (2)
Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)
EXPERIMENTALUse of emollient (Doublebase Gel® or Diprobase Cream®) plus best practice skin care advice. The advice is given in the form of a booklet containing advice on skin care. This will contain information on avoiding soap etc. It will also explain how to apply the emollient i.e. in the direction of the hair, all over the child's skin daily for the first year of life. Intervention group will receive both emollients and parents are asked to choose their preferred.
Best practice skin care advice booklet
ACTIVE COMPARATORThis is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Interventions
Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Eligibility Criteria
You may qualify if:
- child has a first degree relative with parental reported doctor diagnosis of eczema, allergic rhinitis or asthma
- child up to 21 days old
- consenting adult has the ability to understand English
You may not qualify if:
- preterm birth (defined as birth prior to 37 weeks gestation)
- sibling (including twin) previously randomized to this trial. If multiple births, the first child will be randomized into the trial.
- child has a severe widespread skin condition that would make the detection and/or assessment or eczema difficult
- child has a serious health issue, which, at parent or investigator discretion, would make it difficult for the family to take part in the trial
- any condition that would make the use of emollient inadvisable or not possible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
School of Social and Community Medicine, University of Bristol
Bristol, United Kingdom
Queens Hospital
Burton, United Kingdom
Derby Childrens Hosptia
Derby, United Kingdom
Harrogate District Hospital
Harrogate, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Clapham Park Group Practice
London, United Kingdom
Francis Grove Medical Practice
London, United Kingdom
Park Group Practice
London, United Kingdom
St John's Institute of Dermatology
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Streatham Common Medical Practice
London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
St Mary's Hospital
Portsmouth, United Kingdom
Academic Unit of Dermatology Research, Univeristy of Sheffield
Sheffield, United Kingdom
Kings Mill Hospital
Sutton in Ashfield, United Kingdom
York Hospital
York, United Kingdom
Related Publications (3)
Bradshaw LE, Wyatt LA, Brown SJ, Haines RH, Montgomery AA, Perkin MR, Lawton S, Sach TH, Chalmers JR, Ridd MJ, Flohr C, Brooks J, Swinden R, Mitchell EJ, Tarr S, Jay N, Thomas KS, Allen H, Cork MJ, Kelleher MM, Simpson EL, Lartey ST, Davies-Jones S, Boyle RJ, Williams HC. Emollients for prevention of atopic dermatitis: 5-year findings from the BEEP randomized trial. Allergy. 2023 Apr;78(4):995-1006. doi: 10.1111/all.15555. Epub 2022 Nov 3.
PMID: 36263451RESULTChalmers JR, Haines RH, Bradshaw LE, Montgomery AA, Thomas KS, Brown SJ, Ridd MJ, Lawton S, Simpson EL, Cork MJ, Sach TH, Flohr C, Mitchell EJ, Swinden R, Tarr S, Davies-Jones S, Jay N, Kelleher MM, Perkin MR, Boyle RJ, Williams HC; BEEP study team. Daily emollient during infancy for prevention of eczema: the BEEP randomised controlled trial. Lancet. 2020 Mar 21;395(10228):962-972. doi: 10.1016/S0140-6736(19)32984-8. Epub 2020 Feb 19.
PMID: 32087126RESULTBradshaw LE, Montgomery AA, Williams HC, Chalmers JR, Haines RH. Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial. Trials. 2020 Jun 8;21(1):529. doi: 10.1186/s13063-020-04373-4.
PMID: 32546180RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hywel Williams
Centre of Evidence-Based Dermatology, University of Nottingham.
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
- SPONSOR
Study Record Dates
First Submitted
December 8, 2015
First Posted
December 23, 2020
Study Start
November 1, 2014
Primary Completion
December 1, 2018
Study Completion
January 1, 2022
Last Updated
November 28, 2022
Record last verified: 2022-11