Faculty, Staff and Student Publications

Language

English

Publication Date

10-1-2023

Journal

Health Technology Assessment

DOI

10.3310/GZQW6681

PMID

37924282

PMCID

PMC10679965

PubMedCentral® Posted Date

10-27-2023

PubMedCentral® Full Text Version

Post-print

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

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.

Keywords

Child, Female, Humans, Male, Cost-Benefit Analysis, Dermatitis, Atopic, Eczema, Emollients, Ointments, Quality of Life, Severity of Illness Index, Child, Preschool

Comments

TRIAL REGISTRATION: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34.

Published Open-Access

yes

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