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.

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.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Other: Experimental (Doublebase Gel® or Diprobase Cream®); Other: Best practice skin care advice booklet

• Study Type: Interventional
• Enrollment (Actual): 1394
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months
Presence of visible eczema at 24 months (skin examination by researcher).	Presence of visible eczema at 24 months (skin examination by researcher).	24 months
Time to onset of eczema	First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.	24 months
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.	Upto 24 months
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).	Upto 24 months
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.	Upto 24 months
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).	Up to 24 months
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.	Up to 24 months
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.	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema	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	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	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
Severity of eczema at 36, 48, and 60 months as measured by POEM	Severity of eczema at 36, 48, and 60 months as measured by Patient Oriented Eczema Measure (POEM)	36, 48, and 60 months
Parental reported wheezing, at 36, 48 and 60 months	Parental reported wheezing, at 36, 48 and 60 months	36, 48 and 60 months
Parental reported allergic rhinitis at 36, 48 and 60 months	Parental reported allergic rhinitis at 36, 48 and 60 months	36, 48 and 60 months
Parental reported food allergy symptoms at 36, 48 and 60 months	Parental reported food allergy symptoms at 36, 48 and 60 months	36, 48 and 60 months
Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months	Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months	By 60 months
Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months	Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months	36, 48 and 60 months
CHU-9D at 36, 48 and 60 months in order to estimate QALYs	Child health utility 9 dimension (CHU-9D) at 36, 48 and 60 months in order to estimate quality adjusted life years (QALYs)	36, 48 and 60 months
Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs	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)	36, 48 and 60 months
Health care resource use at 36, 48 and 60 months	Health care resource use at 36, 48 and 60 months	36, 48 and 60 months
Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)	Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)	60 months
Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months	Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months	12 months to 60 months
Parental report of clinical diagnosis of food allergy by 60 months	Parental report of clinical diagnosis of food allergy by 60 months	By 60 months

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Hywel Williams, Centre of Evidence-Based Dermatology, University of Nottingham.

Publications and helpful links

General Publications

• 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. 2022 Oct 19. doi: 10.1111/all.15555. [Epub ahead of print]
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: 14044