Barrier Enhancement for Eczema Prevention

Eczema Clinical Trial

— BEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680520
• Other study ID #: 14044
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2022
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 practice infant skin care advice only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1394
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Days

Eligibility

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

Related Conditions & MeSH terms

• Eczema

Intervention

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.
• 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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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 — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema	Presence of eczema in the previous year at 36, 48 and 60 months based on parental report of a clinical diagnosis of eczema	36, 48 and 60 months
Other	Any parental report that in their opinion their child has eczema at 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, 6, 12, 24, 36, 48 and 60 months
Other	Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis	Presence of eczema at 36, 48 and 60 months based on completion by parents of UK Working Party Diagnostic Criteria for Atopic Dermatitis	36, 48 and 60 months
Other	Severity of eczema at 36, 48, and 60 months as measured by POEM	Severity of eczema at 36, 48, and 60 months as measured by Patient Oriented Eczema Measure (POEM)	36, 48, and 60 months
Other	Parental reported wheezing, at 36, 48 and 60 months	Parental reported wheezing, at 36, 48 and 60 months	36, 48 and 60 months
Other	Parental reported allergic rhinitis at 36, 48 and 60 months	Parental reported allergic rhinitis at 36, 48 and 60 months	36, 48 and 60 months
Other	Parental reported food allergy symptoms at 36, 48 and 60 months	Parental reported food allergy symptoms at 36, 48 and 60 months	36, 48 and 60 months
Other	Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months	Parental report of a clinical diagnosis of asthma or allergic rhinitis by 60 months	By 60 months
Other	Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months	Parental report of a clinical diagnosis of food allergy at 36, 48 and 60 months	36, 48 and 60 months
Other	CHU-9D at 36, 48 and 60 months in order to estimate QALYs	Child health utility 9 dimension (CHU-9D) at 36, 48 and 60 months in order to estimate quality adjusted life years (QALYs)	36, 48 and 60 months
Other	Parental quality of life measured using EQ-5D-5L at 36, 48 and 60 months in order to estimate parental QALYs	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)	36, 48 and 60 months
Other	Health care resource use at 36, 48 and 60 months	Health care resource use at 36, 48 and 60 months	36, 48 and 60 months
Other	Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)	Cost utility and cost-effectiveness at 60 months (combining health resource use and health-related quality of life outcomes)	60 months
Other	Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months	Parental report of clinical diagnosis of eczema from the age of 12 months to 60 months	12 months to 60 months
Other	Parental report of clinical diagnosis of food allergy by 60 months	Parental report of clinical diagnosis of food allergy by 60 months	By 60 months
Primary	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	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
Secondary	Presence of visible eczema at 24 months (skin examination by researcher).	Presence of visible eczema at 24 months (skin examination by researcher).	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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