Choice Of Moisturiser in Eczema Treatment (COMET)
| ISRCTN | ISRCTN21828118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21828118 |
| EudraCT/CTIS number | 2013-003001-26 |
| Secondary identifying numbers | 16571 |
- Submission date
- 01/05/2014
- Registration date
- 01/05/2014
- Last edited
- 21/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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 General Practitioner (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. This is a problem because patients may have to make several appointments before they are given an emollient that works for them and it may be that older, cheaper emollients are as good as, or better, than newer, more expensive ones. We want to find out whether it is possible to conduct a large study that will answer the question 'What is the most clinically and cost effective primary emollient to use in infants with eczema?'.
Who can participate?
Parents/carers of 160 children with eczema who are younger than 3 years old can participate in this study.
What does the study involve?
Participants will be prescribed at random one of four widely available emollients (either a cream, a lotion, a gel or an ointment) to use regularly for 3 months. During this time carers will be asked to complete daily diaries about their child's symptoms and use of emollients and other treatments for eczema, and a researcher will assess the severity of eczema at monthly intervals.
What are the possible benefits and risks of participating?
At the end of this study we will have some useful information about the use of emollients and how to assess their effectiveness. We will also be able to decide if it is possible to conduct a larger study. Findings from this and the future study will improve the decision making around which emollient to prescribe first in infants with eczema.
Where is the study run from?
The study is being run by the University of Bristol, in collaboration with 16 GP practices throughout Bristol, North Somerset and South Gloucestershire, UK.
When is the study starting and how long is it expected to run for?
The study starts in June 2014 and runs until August 2015.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Victoria J Wilson
Victoria.Wilson@bristol.ac.uk
Contact information
Scientific
Centre for Academic Primary Care, School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| Victoria.Wilson@bristol.ac.uk |
Study information
| Study design | Feasibility study of a single-centre four-arm single-masked randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Choice Of Moisturiser in Eczema Treatment (COMET): a feasibility study for a pragmatic, single blind, randomised clinical trial to compare the clinical and cost effectiveness of leave-on emollients in treatment of infant eczema in primary care |
| Study acronym | COMET |
| Study hypothesis | Can a study comparing the effectiveness of four different moisturisers used to treat children with eczema be done? |
| Ethics approval(s) | 13/SW/0297; First MREC approval date 19/11/2013 |
| Condition | Topic: Children, Primary Care; Subtopic: All Diagnoses, Not Assigned; Disease: All Diseases, All Diseases |
| Intervention | The participants will be randomised to receive one of four commonly prescribed emollients (Diprobase® cream, Aveeno® lotion, Doublebase® gel or Hydromol® ointment), with directions to apply topically twice daily and throughout the day as required. They will be followed up every 28 days by the clinical studies officers, for 3 months. |
| Intervention type | Other |
| Primary outcome measure | Adherence and retention; Timepoint(s): 3 months |
| Secondary outcome measures | 1. Blinding; Timepoint(s): 3 months 2. Data completeness; Timepoint(s): 3 months 3. EASI; Timepoint(s): Day 0, 28, 56 & 84 4. MCID of biophysical and objective eczema severity measures; Timepoint(s): 0, 1, 2 and 3 months 5. POEM; Timepoint(s): Weekly for 84 days 6. SASSAD; Timepoint(s): Day 0, 28, 56 & 84 7. TIS; Timepoint(s): Day 0, 28, 56 & 84 |
| Overall study start date | 01/06/2014 |
| Overall study end date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 3 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 160; UK Sample Size: 160 |
| Participant inclusion criteria | 1. Children aged between 1 month and 3 years of age with doctor-diagnosed eczema 2. Adult with parental responsibility available to give consent Target Gender: Male & Female; Upper Age Limit 3 years ; Lower Age Limit 1 months |
| Participant exclusion criteria | Child known to be sensitive or allergic to any of study emollients or their constituents |
| Recruitment start date | 01/06/2014 |
| Recruitment end date | 31/08/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS8 2PS
United Kingdom
Sponsor information
University/education
Research & Enterprise Development (RED)
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 2PS
England
United Kingdom
"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 | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/07/2015 | Yes | No | |
| Results article | results | 16/11/2016 | Yes | No | |
| Results article | results | 17/11/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/11/2016: Publication reference added.
18/11/2016: Publication reference added.
