Condition category
Skin and Connective Tissue Diseases
Date applied
08/05/2017
Date assigned
05/06/2017
Last edited
05/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Eczema is a common childhood condition where the skin is dry and itchy. It is usually diagnosed in the first two years of life and in the UK most children are treated by their GP. Moisturisers (emollients) are the main treatment for eczema, but there are many types and we do not know whether one is better than another. The aim of this study is to investigate the effectiveness and acceptability of the main types of emollients - lotion, cream, gel and ointment - in children with eczema to find out which works best.

Who can participate?
Children aged six months to twelve years old who have eczema

What does the study involve?
Participants are randomly allocated into one of four groups. Those in the first group are provided with lotion, those in the second with cream, those in the third with gel, and those in the fourth with ointment. Prescriptions are issued with directions to apply twice daily and as required, and participants are advised to use their allocated treatment as the only leave-on emollient for 16 weeks. After this time, participants can continue to use their allocated emollient or switch to another one. At the start of the study and then after 16 and 52 weeks, participants undergo an examination to see if their eczema has improved.

What are the possible benefits and risks of participating?
Using the study moisturiser as recommended may improve the symptoms of eczema for participants. However, this cannot be guaranteed. There is a risk that participants may experience side effects from using the moisturisers (e.g. skin reactions related to their use, possible slips or falls due to use). In addition, participants may either not like the emollient they are given and/or it may not be helpful for their eczema.

Where is the study run from?
25 GP practices in Clinical Research Networks (CRNs) located in Bristol, Southampton and Leicester (UK)

When is the study starting and how long is it expected to run for?
May 2017 to August 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Sian Wells
bee-study@bristol.ac.uk

Trial website

http://www.bristol.ac.uk/bee-study

Contact information

Type

Public

Primary contact

Ms Sian Wells

ORCID ID

http://orcid.org/0000-0002-5334-7599

Contact details

Office 4.09 Canynge Hall
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44 117 928 7308
bee-study@bristol.ac.uk

Additional identifiers

EudraCT number

2017-000688-34

ClinicalTrials.gov number

Protocol/serial number

34197

Study information

Scientific title

The Best Emollient for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four commonly prescribed emollients for children with eczema

Acronym

BEE

Study hypothesis

The aim of this study is to investigate the effectiveness and acceptability of the main types of emollients - lotion, cream, gel and ointment - in children with eczema.

Ethics approval

South West – Central Bristol Research Ethics Committee, 31/05/2017, ref: 17/SW/0089

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Skin/ Dermatitis and eczema

Intervention

Participants are randomised to one of the four intervention groups: Aveeno® lotion, Diprobase® cream, Doublebase® gel or Epaderm® ointment. Randomisation will be according to a 1:1:1:1 ratio, stratified by centre and minimised by baseline eczema severity (mild versus moderate/severe) and participant age (less than 2 years old versus 2 years and above).

Prescriptions will be issued with directions to apply twice daily and as required, and participants are advised to use their allocated emollient as the only leave-on emollient for 16 weeks. Beyond 16 weeks, participants can continue to use their allocated emollient or switch to another one. Clinical management of eczema will otherwise be as usual – with treating clinicians and participants free to make clinic appointments, referrals and to continue to use or change other treatments (including topical corticosteroids) as normal.

Follow-up for all study arms is 52 weeks.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Parent-reported eczema symptoms measured using the Patient-Oriented Eczema Measure (POEM) weekly for 16 weeks.

Secondary outcome measures

1. Parent-reported eczema symptoms are measured by the Patient Oriented Eczema Measure (POEM), monthly for 52 weeks
2. Eczema signs are assessed using the Eczema and Area Severity Index (EASI), by blinded assessor at baseline and 16 weeks
3. Parent-reported use of study emollient/other eczema treatments are measured with items constructed for the study, weekly for 16 weeks and then monthly until 52 weeks
4. Satisfaction with study emollient is assessed with items constructed for the study (parent/participant self-report) at 16 weeks
5. Adverse effects (localised reactions – such as itching, burning, redness/inflammation, pain, skin infections – and slips and falls) are assessed with items constructed for the study (parent/participant self-report), weekly for 16 weeks and then monthly until 52 weeks
6. Parent-reported personal costs and healthcare contacts are measured with items constructed for the study monthly until 52 weeks, while further healthcare professional contacts and prescriptions of relevant treatments are collected from participant’s electronic medical record (EMR) after 52 weeks
7. The impact of eczema on participants' quality of life is measured using the Atopic Dermatitis Quality of Life (ADQoL) questionnaire at baseline, 6, 16 and 52 weeks
8. The quality of life of participants is assessed using the Child Health Utility 9D ( CHU-9D) at baseline, 6, 16 and 52 weeks
9. The impact of the participant's eczema on the family's quality of life is measured using the Dermatitis Family Impact (DFI) questionnaire at baseline, 16 and 52 weeks
10. Acceptability of study emollients and study procedures are measured with items constructed for the study (parent/participant self-report of acceptability at baseline and 16 weeks, and of study procedures at 52 weeks) and with semi-structured qualitative interviews (approximately 2-4 weeks post-randomisation and after 16 weeks)

Overall trial start date

01/05/2017

Overall trial end date

31/08/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Children:
1. Aged between 6 months and less than 12 years of age
2. Have eczema diagnosed by an appropriately qualified healthcare professional (registered doctor, nurse or health visitor)
3. Have mild eczema or worse (POEM score>2)

Person giving consent:
1. Have parental responsibility for the participant
2. Willing to use the randomly allocated emollient as the only leave-on emollient for 16 weeks.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 520; UK Sample Size: 520

Participant exclusion criteria

Child:
1. Known sensitivity to study emollients or their constituents
2. Participating in another research study currently or in the last four months
3. Any other known adverse medical or social circumstance that would make invitation to the study inappropriate (as determined by GP practice staff)

The person giving consent:
1. Unable to give informed consent
2. Insufficient written English to complete outcome measures.

Recruitment start date

01/09/2017

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR CRN West of England
Whitefriars Lewins Mead
Bristol
BS1 2NT
United Kingdom

Trial participating centre

NIHR CRN Wessex
Unit 7 Berrywood Business Village Tollbar Way Hedge End
Southampton
SO30 2UN
United Kingdom

Trial participating centre

NIHR CRN East Midlands
First Floor Knighton Street Outpatients Building Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 117 928 9827
research-governance@bristol.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial will be publicised from the outset to academic and non-academic audiences including commissioners, clinicians, service providers and self-help groups (e.g. National Eczema Society). In addition to our final monograph for the NIHR HTA Programme, the trial results will be published in peer-reviewed journals and presented at national and international meetings approximately one year after the trial ends. Opportunities for press releases and media interviews, and dissemination via Academic Health Science Network (AHSN) (Network of Networks), will also be sought.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (the University of Bristol data repository).

Intention to publish date

31/08/2021

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes