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Completed

NCT Number: NCT04680520

Barrier Enhancement for Eczema Prevention

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.

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Key information

Conditions

Eczema Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental (Doublebase Gel® or Diprobase Cream®)

Other

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

Other

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

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).

    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 outcomes

  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.

Other outcomes

  1. 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

    Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema

  2. 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

    Any parental report that in their opinion their child has eczema at 3, 6, 12, 24, 36, 48 and 60 months

  3. 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

    Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis

  4. Severity of eczema at 36, 48, and 60 months as measured by POEM

    Time frame: 36, 48, and 60 months

    Severity of eczema at 36, 48, and 60 months as measured by Patient Oriented Eczema Measure (POEM)

  5. Parental reported wheezing, at 36, 48 and 60 months

    Time frame: 36, 48 and 60 months

    Parental reported wheezing, at 36, 48 and 60 months

  6. Parental reported allergic rhinitis at 36, 48 and 60 months

    Time frame: 36, 48 and 60 months

    Parental reported allergic rhinitis at 36, 48 and 60 months

  7. Parental reported food allergy symptoms at 36, 48 and 60 months

    Time frame: 36, 48 and 60 months

    Parental reported food allergy symptoms at 36, 48 and 60 months

  8. Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months

    Time frame: By 60 months

    Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months

  9. Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months

    Time frame: 36, 48 and 60 months

    Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months

  10. CHU-9D at 36, 48 and 60 months in order to estimate QALYs

    Time frame: 36, 48 and 60 months

    Child health utility 9 dimension (CHU-9D) at 36, 48 and 60 months in order to estimate quality adjusted life years (QALYs)

  11. Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs

    Time frame: 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 quality adjusted life years (QALYs)

  12. Health care resource use at 36, 48 and 60 months

    Time frame: 36, 48 and 60 months

    Health care resource use at 36, 48 and 60 months

  13. Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)

    Time frame: 60 months

    Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)

  14. Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months

    Time frame: 12 months to 60 months

    Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months

  15. Parental report of clinical diagnosis of food allergy by 60 months

    Time frame: By 60 months

    Parental report of clinical diagnosis of food allergy by 60 months

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

A Randomised Controlled Trial to Determine Whether Application of Emollient From Birth Can Prevent Eczema in High Risk Children.

Acronym: BEEP

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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