Outputs
Lay summary
Why did we do the study?
Eczema is a common long term condition that causes dry and itchy skin. Emollients (moisturisers) are prescribed on the NHS every day to relieve symptoms and prevent “flares”. However, there are many different types (from watery lotions to thick ointments) and very little research into whether one is any better than another. We wanted to find out whether it is possible to do a randomised clinical trial (a “fair test”) to compare four of the most commonly prescribed ones (Aveeno® lotion, Diprobase® cream, Doublebase® gel and Hydromol® ointment).
What did we want to find out?
To do a full clinical trial is expensive and time consuming, so in this feasibility study we wanted to be sure that:
- GPs/nurses and parents of children with eczema would be willing to take part – and if so, which was the best way to recruit people into the study
- Parents would be willing to be followed-up for 3 months and complete daily diaries (which ask about eczema-related treatments, appointments and costs)
- We would be able to collect all the information needed for a larger trial, such as different measures of effectiveness (parent and researcher reported).
- We could keep the researchers impartial by not telling them which type of emollient the child was using.
How did we do it?
Between June 2014 and April 2015, we asked GP surgeries in Bristol, North Somerset and South Gloucestershire to:
- Send out invitation letters on our behalf, hand out leaflets and display posters in their waiting rooms
- Ask parents/carers who came to the surgery with their children to take part
People willing to take part were given a prescription for one of the four study emollients and asked to use it as their child’s main moisturiser for 3 months. During this time they also had 4 visits from a researcher who independently assessed the child’s skin.
What did we find out?
- Lots of GP surgeries were keen to support the study – more than we needed. In the end 22 took part, 16 of which invited people to take part during a GP or nurse consultation at the surgery.
- We exceeded our original target of 160 participants –by the end 197 children took part. Most children had mild (33%) or moderately (42%) severe eczema. We found that:
- 77% children attended the final follow-up visit. People who self-referred were more likely to attend this (92%) than those approached during GP/nurse consultations (59%).
- Most participants attended most of the baseline and follow-up visits.
- The most common reason given for not completing the study was lack of time.
- The majority (>80%) of participants liked the daily diary.
- There weren’t any clear difference in terms of how regularly the different emollients were applied.
- It was generally possible to keep the emollient that each child was using secret from the researcher who did the follow-up visits.
What happens next?
We have sent a summary to the families and practices that took part, and we will now share our findings more widely with researchers, clinicians and other parents. We have shown that a large trial, which will be able to show whether one emollient is better than another, is possible and the results have the potential to improve quality of life for affected children. We have submitted an application to undertake this trial via one of the other NIHR funding streams (HTA).
Academic papers
1. Ridd Matthew J, Redmond Niamh M, Hollinghurst Sandra, Ball Nicola, Shaw Lindsay, Guy Richard, Wilson Victoria, Metcalfe Chris, Purdy Sarah. Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial." Trials 2015; 16(1): 304. http://www.
2. Matthew J Ridd, Kirsty Garfield, Daisy M Gaunt, Sandra Hollinghurst, Niamh M Redmond, Kingsley Powell, Victoria Wilson, Richard H Guy, Nicola Ball, Lindsay Shaw, Sarah Purdy, Chris Metcalfe. Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care. BMJ Open 2016 DOI:10.1136/bmjopen-2016-012021
3. Daisy M Gaunt, Chris Metcalfe and Matthew Ridd, The Patient-Oriented Eczema Measure in young children: responsiveness and minimal clinically important difference. Allergy 2016 DOI: 10.1111/all.12942
4. Kingsley Powell, Victoria J. Wilson, Niamh M. Redmond, Daisy M. Gaunt, Matthew J. Ridd. Exceeding the recruiment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial. Trials 2016; 17: 550. DOI10.1186/s13063-016-1659-8
5. Ridd M J, Gaunt D M, Guy R H, Redmond N M, Garfield Kirsty, Hollinghurst Sandra, Ball Nicola, Shaw Lindsay, Purdy Sarah, Metcalfe C. Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility trial. British Journal of Dermatology. BJD 2018; 179: 362-370 DOI: 10.1111/bjd.16475
Oral presentations at conferences
1. Powell K, Wilson V, Redmond N M, Gaunt D, Ball N, Shaw L, Hollinghurst S, Metcalfe C, Lane A, Guy R, Purdy P, Ridd M J. Exceeding the recruitment target in a primary care paediatric trial: lessons from the COMET study. South-West SAPC Meeting, Cardiff March 2016.
2. Thomas K, Bradshaw L, Montgommery A, Francis N, Ridd M, Santer M. Using existing trial data to inform the development of core outcome sets and improve efficiencies in research. International Clinical Trials Methodology Conference, Glasgow November 2015. [Abstract in Trials 2015; 16 (Suppl 2): O74]
3. Ridd Matthew, Wilson Victoria, Powell Kingsley, Folkes Elizabeth, Redmond Niamh, Hollinghurst Sandra, Garfield Kirsty, Ball Nicola, Shaw Lindsay, Lane Athene, Guy Richard, Metcalfe Chris, Gaunt Daisy, Purdy Sarah. Feasibility of a randomized trial comparing different emollients for childhood eczema: findings from Choice of Moisturiser in Eczema Treatment (COMET) study. Society for Academic Primary Care Annual Scientific Meeting, Oxford July 2015.
4. Ridd M, Gaunt D M, Garfield K, Hollinghurst S, Redmond N M, Guy R, Ball N, Shaw L, Purdy S, Metcalfe C. Effectiveness and acceptability of four commonly used leave-on emollients in the treatment of childhood eczema. British Association of Dermatologists, July 2016.
5. Gaunt D, Metcalfe C, Ridd M. The patient-oriented eczema measure of eczema severity in young children: responsiveness and minimal clinically important difference. British Association of Dermatologists, July 2016.
6. Rowley G G, MacNeill S J, Ridd M J. Emollient satisfaction questionnaire: validation study in children with eczema. Clin Exp Dermatol 2022; DOI: 10.1111/ced.15189
Posters presented at conferences
1. Matthew Ridd, Niamh Redmond, Sandra Hollinghurst, Chris Metcalfe, Athene Lane, Richard Guy, Nicola Ball, Lindsay Shaw, Sarah Purdy. Choice of Moisturiser in Eczema Treatment (COMET): feasibility study protocol. South-West regional meeting of the SAPC, Bristol March 2014.
2. Matthew Ridd, Niamh Redmond, Sandra Hollinghurst, Chris Metcalfe, Athene Lane, Richard Guy, Nicola Ball, Lindsay Shaw, Sarah Purdy. Choice of Moisturiser in Eczema Treatment (COMET): feasibility study protocol. International Symposium on Atopic Dermatitis, Nottingham May 2014.
3. Jacquet L, Gaunt D M, Garfield K, Powell K, Ridd M J. Diagnosis, assessment and treatment of eczema in primary care: cross-sectional study. South-West SAPC Meeting, Cardiff March 2016
4. Jacquet L, Gaunt D M, Garfield K, Ridd M J. Diagnosis, assessment and treatment of eczema in primary care: cross-sectional study. British Association of Dermatologists, July 2016.