Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1394 participants
INTERVENTIONAL
2014-11-01
2022-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)
Use 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.
Experimental (Doublebase Gel® or Diprobase Cream®)
Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.
Best practice skin care advice booklet
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Best practice skin care advice booklet
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Best practice skin care advice booklet
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Interventions
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Experimental (Doublebase Gel® or Diprobase Cream®)
Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.
Best practice skin care advice booklet
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Eligibility Criteria
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Inclusion Criteria
* child up to 21 days old
* consenting adult has the ability to understand English
Exclusion Criteria
* 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
21 Days
ALL
Yes
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Hywel Williams
Role: PRINCIPAL_INVESTIGATOR
Centre of Evidence-Based Dermatology, University of Nottingham.
Locations
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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
Countries
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References
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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.
Chalmers 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.
Bradshaw 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.
Other Identifiers
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14044
Identifier Type: -
Identifier Source: org_study_id
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