Best emollients for eczema
| ISRCTN | ISRCTN84540529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84540529 |
| EudraCT/CTIS number | 2017-000688-34 |
| IRAS number | 214900 |
| Secondary identifying numbers | 34197, IRAS 214900 |
- Submission date
- 08/05/2017
- Registration date
- 05/06/2017
- Last edited
- 06/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Current plain English summary as of 12/08/2019:
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?
GP practices in Clinical Research Networks (CRNs) - West of England, Wessex and East Midlands (UK)
When is the study starting and how long is it expected to run for?
May 2017 to May 2021 (updated 17/02/2021, previously: February 2021 (updated 18/03/2020, previously: June 2021))
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Sian Wells
bee-study@bristol.ac.uk
Previous 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 Nottingham (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
Contact information
Public
Office G.15
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-5334-7599 |
|---|---|
| Phone | +44 117 928 7308 |
| bee-study@bristol.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | ISRCTN84540529_PIS_v3.0_03Nov2017.pdf |
| Scientific title | The Best Emollients for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four types of commonly prescribed emollients for children with eczema |
| Study acronym | BEE |
| Study objectives | 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(s) | South West – Central Bristol Research Ethics Committee, 31/05/2017, ref: 17/SW/0089 |
| Health condition(s) or problem(s) studied | Atopic dermatitis |
| Intervention | Current version as of 03/04/2018: Participants are randomised to one of the four intervention groups: Lotion, Cream, Gel or 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. Original version: 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 |
| Primary outcome measure | 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 study start date | 01/05/2017 |
| Completion date | 31/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 520; UK Sample Size: 520 |
| Total final enrolment | 550 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/10/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Lewins Mead
Bristol
BS1 2NT
United Kingdom
Berrywood Business Village
Tollbar Way
Hedge End
Southampton
SO30 2UN
United Kingdom
Knighton Street Outpatients Building
Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom
Sponsor information
University/education
Research & Enterprise Development
University of Bristol
Trinity Street
College Green
One Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 117 928 9827 |
|---|---|
| research-governance@bristol.ac.uk | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/11/2019 | 17/02/2021 | Yes | No |
| Results article | 23/05/2022 | 26/05/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Parent/Carer Consent Form and Assent Form for children version 3.0 |
03/11/2017 | 11/07/2023 | No | Yes |
| Results article | 01/10/2023 | 06/11/2023 | Yes | No |
Additional files
- ISRCTN84540529_PIS_v3.0_03Nov2017.pdf
- Parent/Carer Consent Form and Assent Form for children
Editorial Notes
06/11/2023: Publication reference added.
11/07/2023: The following changes were made:
1. Participant information sheet uploaded.
2. IRAS number added.
26/05/2022: Publication reference added.
17/02/2021: The following changes were made to the trial record:
1. The overall end date was changed from 28/02/2021 to 31/05/2021.
2. The intention to publish date was changed from 28/02/2021 to 01/09/2021.
3. The plain English summary was updated to reflect these changes.
4. Publication reference added.
18/03/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/02/2020 to 31/10/2019.
2. The overall end date was changed from 30/06/2021 to 28/02/2021.
3. The intention to publish date was changed from 30/06/2022 to 28/02/2021.
4. The plain English summary was updated to reflect these changes.
5. The public title was changed from "Best emollient for eczema" to "Best emollients for eczema".
6. The scientific title has been changed from "The Best Emollient for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four types of commonly prescribed emollients for children with eczema" to "The Best Emollients for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four types of commonly prescribed emollients for children with eczema"
7. The total final enrolment was added.
12/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2019 to 29/02/2020.
2. The overall end date was changed from 31/12/2020 to 30/06/2021.
3. The public contact details have been updated.
4. The sponsor contact details have been updated.
5. The plain English summary has been updated.
6. The intention to publish date has been changed from 31/12/2021 to 30/06/2022.
08/05/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2019 to 31/08/2019.
2. The overall end date was changed from 31/08/2020 to 31/12/2020.
3. The intention to publish date was changed from 31/08/2021 to 31/12/2021.
25/04/2019: Internal review.
03/04/2019: The condition has been changed "Specialty: Children, Primary sub-specialty: General Paediatrics; UKCRC code/ Disease: Skin/ Dermatitis and eczema" to "Atopic dermatitis" following a request from the NIHR.
03/04/2018: The following changes have been made:
1. The scientific title has been changed from "The Best Emollient for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four commonly prescribed emollients for children with eczema" to "The Best Emollient for Eczema (BEE) trial: a randomised trial comparing the effectiveness of four types of commonly prescribed emollients for children with eczema"
2. The trial setting has been changed from 'Hospitals' to 'GP practices'.
3. A patient information sheet link has been added.
4. The interventions have been changed.
5. The Participant inclusion criteria: Age group has been changed from 'Adult' to 'Child'.
6. The recruitment start date has been changed from 01/09/2017 to 01/01/2018.
