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Barrier Enhancement for Eczema Prevention (BEEP)

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ClinicalTrials.gov Identifier: NCT04680520
Recruitment Status : Active, not recruiting
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eczema Other: Experimental (Doublebase Gel® or Diprobase Cream®) Other: Best practice skin care advice booklet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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). [ Time Frame: 24 months ]
    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 :
  1. Presence of parental report of eczema between birth and 24 months. [ Time Frame: Up to 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.


  2. Presence of visible eczema at 24 months (skin examination by researcher). [ Time Frame: 24 months ]
    Presence of visible eczema at 24 months (skin examination by researcher).

  3. Time to onset of eczema [ Time Frame: 24 months ]
    First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.

  4. Presence of other allergic diseases using parental reports, allergic sensitization and confirmed diagnosis [ Time Frame: Upto 24 months ]

    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.


  5. Child health-related quality adjusted life years. [ Time Frame: Upto 24 months ]
    Child health utility 9 dimension (CHU-9D) at 24 months in order to estimate quality adjusted life years (QALYs).

  6. Parental health-related quality adjusted life years. [ Time Frame: Upto 24 months ]
    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.

  7. Cost or treatments- health economic outcomes [ Time Frame: Up to 24 months ]
    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).

  8. Severity of eczema with EASI eczema severity scales [ Time Frame: Up to 24 months ]
    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.

  9. Severity of eczema with POEM eczema severity scales [ Time Frame: Up to 24 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680520


Locations
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United Kingdom
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
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Hywel Williams Centre of Evidence-Based Dermatology, University of Nottingham.
More Information
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04680520    
Other Study ID Numbers: 14044
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous