Best emollients for eczema
| ISRCTN | ISRCTN84540529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84540529 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2017-000688-34 |
| Integrated Research Application System (IRAS) | 214900 |
| Protocol serial number | 34197, IRAS 214900 |
| Sponsor | University of Bristol |
| Funder | National Institute for Health Research |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Treatment, Drug |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Parent-reported eczema symptoms measured using the Patient-Oriented Eczema Measure (POEM) weekly for 16 weeks. |
| Key secondary outcome measure(s) |
1. Parent-reported eczema symptoms are measured by the Patient Oriented Eczema Measure (POEM), monthly for 52 weeks |
| Completion date | 31/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
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
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| 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? |
|---|---|---|---|---|---|
| Results article | 23/05/2022 | 26/05/2022 | Yes | No | |
| Results article | 01/10/2023 | 06/11/2023 | Yes | No | |
| Protocol article | protocol | 06/11/2019 | 17/02/2021 | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
