Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: the BEE RCT

Ridd, Matthew J; Wells, Sian; MacNeill, Stephanie J; Sanderson, Emily; Webb, Douglas; Banks, Jonathan; Sutton, Eileen; Shaw, Alison RG; Wilkins, Zoe; Clayton, Julie; Roberts, Amanda; Garfield, Kirsty; Liddiard, Lyn; Barrett, Tiffany J; Lane, J Athene; Baxter, Helen; Howells, Laura; Taylor, Jodi; Hay, Alastair D; Williams, Hywel C; Thomas, Kim S; Santer, Miriam

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.

Citation

Ridd, M. J., Wells, S., MacNeill, S. J., Sanderson, E., Webb, D., Banks, J., Sutton, E., Shaw, A. R., Wilkins, Z., Clayton, J., Roberts, A., Garfield, K., Liddiard, L., Barrett, T. J., Lane, J. A., Baxter, H., Howells, L., Taylor, J., Hay, A. D., Williams, H. C., …Santer, M. (2023). Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: the BEE RCT. Health Technology Assessment, 27(19), 1-120. https://doi.org/10.3310/gzqw6681

• Journal Article Type: Article
• Acceptance Date: Aug 30, 2023
• Online Publication Date: Oct 23, 2023
• Publication Date: Nov 19, 2023
• Deposit Date: Nov 12, 2023
• Publicly Available Date: Nov 15, 2023
• Journal: Health Technology Assessment
• Print ISSN: 1366-5278
• Electronic ISSN: 2046-4924
• Publisher: NIHR Journals Library
• Peer Reviewed: Peer Reviewed
• Volume: 27
• Issue: 19
• Pages: 1-120
• DOI: https://doi.org/10.3310/gzqw6681
• Keywords: Child, Eczema - drug therapy, Emollients, Quality of Life, Male, Severity of Illness Index, Female, Humans, Dermatitis, Atopic - chemically induced - drug therapy, Child, Preschool, Ointments - therapeutic use, Cost-Benefit Analysis
• Public URL: https://nottingham-repository.worktribe.com/output/27089274
• Publisher URL: https://www.journalslibrary.nihr.ac.uk/hta/GZQW6681#/abstract
• Additional Information: Free to read: This content has been made freely available to all. contractual start date: 05-2017; editorial review begun: 06-2021; Accepted for publication: 03-2022. Copyright © 2023 Ridd et al. ; ; This work was produced by Ridd et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed.