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EczemaBEEPNCT04680520

Barrier Enhancement for Eczema Prevention

A study testing Experimental (Doublebase Gel® or Diprobase Cream®) and Best practice skin care advice booklet in people with Eczema, run by University of Nottingham at 16 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 21 daysHealthy volunteers can take part
Conditions the study is for
Eczema
What is being tested?
Experimental (Doublebase Gel® or Diprobase Cream®) and Best practice skin care advice booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,394 participants
Where
16 sitesUnited Kingdom
Study dates
1 Nov 2014to 1 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

16 sites in 1 country.

16 sites in 1 country

United Kingdom16 sites

  • School of Social and Community Medicine, University of Bristol

    Bristol

  • Queens Hospital

    Burton

  • Derby Childrens Hosptia

    Derby

  • Harrogate District Hospital

    Harrogate

  • Leicester Royal Infirmary

    Leicester

  • Clapham Park Group Practice

    London

  • Francis Grove Medical Practice

    London

  • Park Group Practice

    London

  • St John's Institute of Dermatology

    London

  • St Mary's Hospital

    London

  • Streatham Common Medical Practice

    London

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • St Mary's Hospital

    Portsmouth

  • Academic Unit of Dermatology Research, Univeristy of Sheffield

    Sheffield

  • Kings Mill Hospital

    Sutton in Ashfield

  • York Hospital

    York

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Eczema
Being tested
Experimental (Doublebase Gel® or Diprobase Cream®), Best practice skin care advice booklet
Medical subject headings
Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 bookletOther

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

Study groups in NCT04680520
Study groupRoleWhat they receive
Best practice skin care advice booklet plus emollient (Doublebase Gel® or Diprobase Cream®)ExperimentalUse 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.
Receives: Other: Experimental (Doublebase Gel® or Diprobase Cream®); Other: Best practice skin care advice booklet
Best practice skin care advice bookletActive comparatorThis is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
Receives: Other: Best practice skin care advice booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    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

    Measured: 24 months

Secondary outcomes (9)

  1. 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.

    Measured: Up to 24 months

  2. Presence of visible eczema at 24 months (skin examination by researcher).

    Presence of visible eczema at 24 months (skin examination by researcher).

    Measured: 24 months

  3. Time to onset of eczema

    First parental report of a clinical diagnosis of eczema. First topical corticosteroid and /or immunosuppressant prescription for eczema.

    Measured: 24 months

  4. 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.

    Measured: Upto 24 months

  5. 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).

    Measured: Upto 24 months

  6. 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.

    Measured: Upto 24 months

  7. 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).

    Measured: Up to 24 months

  8. 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.

    Measured: Up to 24 months

  9. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start1 Nov 2014
  3. Primary completion1 Dec 2018
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680520
Sponsor's protocol ID
14044
Acronym
BEEP
Status last verified
Nov 2022
First submitted
8 Dec 2015
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
No

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. 2023 Apr;78(4):995-1006. doi: 10.1111/all.15555. Epub 2022 Nov 3.

    PubMed 36263451

  • 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.

    PubMed 32087126

  • 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.

    PubMed 32546180

Questions about this trial

What is this clinical trial studying?

A study testing Experimental (Doublebase Gel® or Diprobase Cream®) and Best practice skin care advice booklet in people with Eczema, run by University of Nottingham at 16 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04680520, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.

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