Abstract
Background:
Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a ‘trial and error’ approach to prescribing.
Objective:
To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema.
Design:
Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks.
Setting:
Primary care (78 general practitioner surgeries) in England.
Participants:
Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents.
Interventions:
Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked.
Main outcome measures:
The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks.
Results:
A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2–8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences – cream–lotion 0.42 (95% confidence interval –0.48 to 1.32), gel–lotion 0.17 (95% confidence interval –0.75 to 1.09), ointment–lotion –0.01 (95% confidence interval –0.93 to 0.91), gel–cream –0.25 (95% confidence interval –1.15 to 0.65), ointment–cream –0.43 (95% confidence interval –1.34 to 0.48) and ointment–gel –0.18 (95% confidence interval –1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial.
Limitations:
Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds.
Conclusions:
The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them.
Future work:
Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and ‘novel’ emollients.
Trial registration:
This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34.
Funding:
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.
Plain language summary
One in five children in the UK have eczema, a long-term, itchy, dry skin condition. It can significantly affect both the child and their family. Most children are diagnosed and looked after by their family doctor (general practitioner) and are prescribed moisturisers (also called emollients) to relieve skin dryness and other creams (topical corticosteroids) to control flare-ups. However, there are many different types of emollients and, to our knowledge, limited research to show which is better.
In the Best Emollients for Eczema clinical trial, we compared the four main types of moisturisers – lotions, creams, gels and ointments. These types vary in their consistency, from thin to thick. We recruited 550 children (most of whom were white and had moderate eczema) and randomly assigned them to use one of the four different types as their main moisturiser for 16 weeks.
We found no difference in effectiveness. Parent-reported eczema symptoms, eczema severity and quality of life were the same for all the four types of moisturisers. However, overall satisfaction was highest for lotions and gels. Ointments may need to be used less and cause less stinging.
We interviewed 44 parents and 25 children who took part. Opinions of all four types of moisturisers varied. What one family liked about a moisturiser was not necessarily the same for another and preferences were individual to each user. Sometimes there was a tension between how well a moisturiser worked (effectiveness) and how easy it was to use (acceptability). In these cases, effectiveness tended to decide whether or not parents kept using it. People found moisturisers in pumps and bottles easier to use than those in tubs. A number of participants valued the information they were given about how to use moisturisers.
Our results suggest that the type of moisturiser matters less than finding one that suits the child and family.
Contents
- Scientific summary
- Chapter 1. Introduction
- Eczema
- Emollients for eczema
- Development of research priority
- Aims and objectives
- Chapter 2. Methods
- Trial design
- Changes to trial protocol
- Terminology and definitions
- Participant recruitment and follow-up
- Intervention
- Outcomes
- Data collection
- Sample size
- Participant randomisation, notification and receipt of allocation
- Masking
- Statistical methods
- Nested qualitative study
- Chapter 3. Patient and public involvement
- Aim and objectives
- Method
- Results
- Discussion and conclusions
- Reflections/critical perspective
- Chapter 4. Trial results
- Participant recruitment
- Participant characteristics
- Allocation and receipt of intervention
- Reported behaviours regarding study emollient use
- Participant follow-up and withdrawals
- Data collection and completeness
- Protocol deviations
- Masking of researcher at week-16 visit
- Outcomes
- Secondary outcomes
- Chapter 5. Nested qualitative study results
- Characteristics of interview participants
- Perceptions of effectiveness of emollients
- Acceptability of emollients
- Emollient containers
- Decision-making at week 16: the effectiveness and acceptability trade-off
- Participant characteristics and perceived effectiveness and acceptability
- Study participation and emollient use
- Interviews with children
- Chapter 6. Discussion
- Main findings
- Strengths and limitations
- Findings in the context of the literature
- Chapter 7. Conclusions
- Recommendations for research
- Implications for health care
- Chapter 8. Knowledge mobilisation
- Key stakeholders
- Relationships between key stakeholders
- Knowledge mobilisation and dissemination strategy
- Acknowledgements
- References
- Appendix 1. Protocol amendments
- Appendix 2. Trial supplementary tables and figures
- Appendix 3. Nested qualitative study
- List of abbreviations
- List of supplementary material
About the Series
Health Technology Assessment
ISSN (Print): 1366-5278
ISSN (Electronic): 2046-4924
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi
Primary conflicts of interest: Alastair D Hay is currently a member of the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation Funding Committee (2019–present) and the National Institute for Health and Care Excellence Managing Common Infections Committee (2016–present). He has previously been a member of the NIHR Health Technology Assessment (HTA) Clinical Evaluation and Trials Committee (2013–17) and the NIHR Programme Grants for Applied Research (PGfAR) funding committee (2007–12). Laura Howells is employed as a research fellow to work on research grants that are funded by NIHR. She also currently acts as a consultant for the University of Oxford (Oxford, UK) on an educational grant funded by Pfizer Inc. (Pfizer Inc., New York, NY, USA), unrelated to the submitted work. J Athene Lane is a member of the NIHR Clinical Trials Unit Standing Advisory Committee (2021–present) and a clinical trials unit funded by NIHR. Stephanie MacNeill is currently a member of the NIHR HTA General Committee (August 2020–present). Matthew J Ridd is a member of NIHR In-Practice Fellowship Selection Committee (2020–present), and was previously a member of the NIHR Systematic Reviews Programme Advisory Group (2019–20) and the NIHR HTA General Committee (2016–19). Amanda Roberts was previously a member of the Pharmaceuticals Panel, and a member of the NIHR HTA General Committee (2017–21) and HTA Fast Track Committee (2010–12). Miriam Santer has received funding for other NIHR projects and is a panel member for NIHR PGfAR (2018–present). Hywel C Williams directed the NIHR HTA programme from 2015 to 2020, which funded this study. He had no role to play in the funding decision.
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 15/130/07. The contractual start date was in May 2017. The draft report began editorial review in June 2021 and was accepted for publication in March 2022. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Last reviewed: June 2021; Accepted: March 2022.
