Barrier Enhancement for Eczema Prevention

Study Overview
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Brief Summary
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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.

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

Conditions
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Eczema

Intervention / Treatment
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* Other: Experimental (Doublebase Gel® or Diprobase Cream®)
* Other: Best practice skin care advice booklet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)<br>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®)<br>* Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.<br>Other: Best practice skin care advice booklet<br>* This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.<br>|
| Active Comparator: Best practice skin care advice booklet<br>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<br>* This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.<br>|

What is the study measuring?
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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 |