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Barrier Enhancement for Eczema Prevention (BEEP)

Primary Purpose

Eczema

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental (Doublebase Gel® or Diprobase Cream®)
Best practice skin care advice booklet
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eczema

Eligibility Criteria

undefined - 21 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • School of Social and Community Medicine, University of Bristol
  • Queens Hospital
  • Derby Childrens Hosptia
  • Harrogate District Hospital
  • Leicester Royal Infirmary
  • Clapham Park Group Practice
  • Francis Grove Medical Practice
  • Park Group Practice
  • St John's Institute of Dermatology
  • St Mary's Hospital
  • Streatham Common Medical Practice
  • Nottingham University Hospitals NHS Trust
  • St Mary's Hospital
  • Academic Unit of Dermatology Research, Univeristy of Sheffield
  • Kings Mill Hospital
  • York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)

Best practice skin care advice booklet

Arm Description

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.

This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presence of parental report of eczema between birth and 24 months.
Assessed using: Any parental report of a clinical diagnosis of eczema. Completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis at 12 and 24 months.
Presence of visible eczema at 24 months (skin examination by researcher).
Presence of visible eczema at 24 months (skin examination by researcher).
Time to onset of eczema
First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.
Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis
Parental reported wheezing and allergic rhinitis between 12 and 24 months. Parental report of a clinical diagnosis of food allergy at 12 and 24 months. Parental report of food allergy at 12 and 24 months. Parents will be specifically questioned about cow's milk, egg, peanuts, and other nuts plus "any other food". Allergic sensitisation at 24 months to any of the following common allergens: milk, egg, peanut, cat, grass pollen, house dust mite. Confirmed diagnosis of food allergy at 24 months to milk, egg, peanut or 'any of milk, egg or peanut'. The diagnosis is derived from a combination of parental report, allergic sensitisation and food challenge.
Child health-related quality adjusted life years.
Child health utility 9 dimension (CHU-9D) at 24 months in order to estimate quality adjusted life years (QALYs).
Parental health-related quality adjusted life years.
Parental quality of life measured using the EQ-5D-5L at baseline and 24 months in order to estimate change in parental QALYs, if any.
Cost or treatments- health economic outcomes
Health care resource use at 3, 6, 12, 18 and 24 months. Cost effectiveness and cost-utility at 24 months (combining health resource use and health-related quality of life outcomes).
Severity of eczema with EASI eczema severity scales
Assessed using eczema area and severity index (EASI) at 24 months. The area score is recorded for each of four regions of the body: head and neck, trunk, upper limbs and lower limbs. The area score is the percentage of skin affected by eczema for each body region. The scores given are from 0-6 where a score of 0 is given when the percentage of skin affected by eczema in the region is 0%, and a score of 6 is given when 90-100% of the region is affected by eczema. The severity score is recorded for each of the four body regions for four signs: redness, thickness, scratching and lichenification. Scores are given from 0-3 where a score of 3 is for most severe signs.
Severity of eczema with POEM eczema severity scales
Assessed using patient oriented eczema measure (POEM) at 12 and 24 months. The scores given are from 0-28, where a score of 28 is for the most severe.

Full Information

First Posted
December 8, 2015
Last Updated
November 21, 2022
Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT04680520
Brief Title
Barrier Enhancement for Eczema Prevention
Acronym
BEEP
Official Title
A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eczema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)
Arm Type
Experimental
Arm Description
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.
Arm Title
Best practice skin care advice booklet
Arm Type
Active Comparator
Arm Description
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Intervention Type
Other
Intervention Name(s)
Experimental (Doublebase Gel® or Diprobase Cream®)
Intervention Description
Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.
Intervention Type
Other
Intervention Name(s)
Best practice skin care advice booklet
Intervention Description
This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Presence of parental report of eczema between birth and 24 months.
Description
Assessed using: Any parental report of a clinical diagnosis of eczema. Completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis at 12 and 24 months.
Time Frame
Up to 24 months
Title
Presence of visible eczema at 24 months (skin examination by researcher).
Description
Presence of visible eczema at 24 months (skin examination by researcher).
Time Frame
24 months
Title
Time to onset of eczema
Description
First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.
Time Frame
24 months
Title
Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis
Description
Parental reported wheezing and allergic rhinitis between 12 and 24 months. Parental report of a clinical diagnosis of food allergy at 12 and 24 months. Parental report of food allergy at 12 and 24 months. Parents will be specifically questioned about cow's milk, egg, peanuts, and other nuts plus "any other food". Allergic sensitisation at 24 months to any of the following common allergens: milk, egg, peanut, cat, grass pollen, house dust mite. Confirmed diagnosis of food allergy at 24 months to milk, egg, peanut or 'any of milk, egg or peanut'. The diagnosis is derived from a combination of parental report, allergic sensitisation and food challenge.
Time Frame
Upto 24 months
Title
Child health-related quality adjusted life years.
Description
Child health utility 9 dimension (CHU-9D) at 24 months in order to estimate quality adjusted life years (QALYs).
Time Frame
Upto 24 months
Title
Parental health-related quality adjusted life years.
Description
Parental quality of life measured using the EQ-5D-5L at baseline and 24 months in order to estimate change in parental QALYs, if any.
Time Frame
Upto 24 months
Title
Cost or treatments- health economic outcomes
Description
Health care resource use at 3, 6, 12, 18 and 24 months. Cost effectiveness and cost-utility at 24 months (combining health resource use and health-related quality of life outcomes).
Time Frame
Up to 24 months
Title
Severity of eczema with EASI eczema severity scales
Description
Assessed using eczema area and severity index (EASI) at 24 months. The area score is recorded for each of four regions of the body: head and neck, trunk, upper limbs and lower limbs. The area score is the percentage of skin affected by eczema for each body region. The scores given are from 0-6 where a score of 0 is given when the percentage of skin affected by eczema in the region is 0%, and a score of 6 is given when 90-100% of the region is affected by eczema. The severity score is recorded for each of the four body regions for four signs: redness, thickness, scratching and lichenification. Scores are given from 0-3 where a score of 3 is for most severe signs.
Time Frame
Up to 24 months
Title
Severity of eczema with POEM eczema severity scales
Description
Assessed using patient oriented eczema measure (POEM) at 12 and 24 months. The scores given are from 0-28, where a score of 28 is for the most severe.
Time Frame
Up to 24 months
Other Pre-specified Outcome Measures:
Title
Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema
Description
Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema
Time Frame
36, 48 and 60 months
Title
Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months
Description
Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months
Time Frame
3, 6, 12, 24, 36, 48 and 60 months
Title
Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis
Description
Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis
Time Frame
36, 48 and 60 months
Title
Severity of eczema at 36, 48, and 60 months as measured by POEM
Description
Severity of eczema at 36, 48, and 60 months as measured by Patient Oriented Eczema Measure (POEM)
Time Frame
36, 48, and 60 months
Title
Parental reported wheezing, at 36, 48 and 60 months
Description
Parental reported wheezing, at 36, 48 and 60 months
Time Frame
36, 48 and 60 months
Title
Parental reported allergic rhinitis at 36, 48 and 60 months
Description
Parental reported allergic rhinitis at 36, 48 and 60 months
Time Frame
36, 48 and 60 months
Title
Parental reported food allergy symptoms at 36, 48 and 60 months
Description
Parental reported food allergy symptoms at 36, 48 and 60 months
Time Frame
36, 48 and 60 months
Title
Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months
Description
Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months
Time Frame
By 60 months
Title
Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months
Description
Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months
Time Frame
36, 48 and 60 months
Title
CHU-9D at 36, 48 and 60 months in order to estimate QALYs
Description
Child health utility 9 dimension (CHU-9D) at 36, 48 and 60 months in order to estimate quality adjusted life years (QALYs)
Time Frame
36, 48 and 60 months
Title
Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs
Description
Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental quality adjusted life years (QALYs)
Time Frame
36, 48 and 60 months
Title
Health care resource use at 36, 48 and 60 months
Description
Health care resource use at 36, 48 and 60 months
Time Frame
36, 48 and 60 months
Title
Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)
Description
Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)
Time Frame
60 months
Title
Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months
Description
Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months
Time Frame
12 months to 60 months
Title
Parental report of clinical diagnosis of food allergy by 60 months
Description
Parental report of clinical diagnosis of food allergy by 60 months
Time Frame
By 60 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hywel Williams
Organizational Affiliation
Centre of Evidence-Based Dermatology, University of Nottingham.
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Social and Community Medicine, University of Bristol
City
Bristol
Country
United Kingdom
Facility Name
Queens Hospital
City
Burton
Country
United Kingdom
Facility Name
Derby Childrens Hosptia
City
Derby
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Clapham Park Group Practice
City
London
Country
United Kingdom
Facility Name
Francis Grove Medical Practice
City
London
Country
United Kingdom
Facility Name
Park Group Practice
City
London
Country
United Kingdom
Facility Name
St John's Institute of Dermatology
City
London
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
Country
United Kingdom
Facility Name
Streatham Common Medical Practice
City
London
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Portsmouth
Country
United Kingdom
Facility Name
Academic Unit of Dermatology Research, Univeristy of Sheffield
City
Sheffield
Country
United Kingdom
Facility Name
Kings Mill Hospital
City
Sutton in Ashfield
Country
United Kingdom
Facility Name
York Hospital
City
York
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36263451
Citation
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.
Results Reference
result
PubMed Identifier
32087126
Citation
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.
Results Reference
result
PubMed Identifier
32546180
Citation
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.
Results Reference
result

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Barrier Enhancement for Eczema Prevention

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