Barrier Enhancement for Eczema Prevention (BEEP)

University of Nottingham

Status: Completed

Conditions: Eczema

Treatments: Other: Best practice skin care advice booklet; Other: Experimental (Doublebase Gel® or Diprobase Cream®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04680520

14044

Details and patient eligibility

About

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.

Enrollment: 1,394 patients

Sex: All

Ages: Under 21 days old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,394 participants in 2 patient groups

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

Experimental group

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.

Treatment:

Other: Experimental (Doublebase Gel® or Diprobase Cream®)

Other: Best practice skin care advice booklet

Best practice skin care advice booklet

Active Comparator group

Description:

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

Treatment:

Other: Best practice skin care advice booklet