Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial

Matthew J Ridd*, Miriam Santer, Stephanie J MacNeill, Emily J Sanderson, Sian L Wells, Doug P S Webb, Jonathan P Banks, Eileen J Sutton, Amanda Roberts, Lyn M Liddiard, Zoe Wilkins, Julie P Clayton, Kirsty M Garfield, Tiffany J Barrett, J. Athene Lane, Helen A Baxter, Laura Howells, Jodi Taylor, Alastair D Hay, Hywel C WilliamsKim S Thomas

*Corresponding author for this work

Research output: Contribution to journalReview article (Academic Journal)peer-review

22 Citations (Scopus)
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Abstract

Background
To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments.

Methods
We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529.

Findings
Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2–8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI −0·48 to 1·32), gel versus lotion 0·17 (−0·75 to 1·09), ointment versus lotion −0·01 (−0·93 to 0·91), gel versus cream −0·25 (−1·15 to 0·65), ointment versus cream −0·43 (−1·34 to 0·48), and ointment versus gel −0·18 (−1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135).

Interpretation
We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively.
Original languageEnglish
Pages (from-to)522-532
Number of pages11
JournalThe Lancet Child and Adolescent Health
Volume6
Issue number8
DOIs
Publication statusPublished - 23 May 2022

Bibliographical note

Funding Information:
LH currently acts as a consultant for the University of Oxford on an educational grant funded by Pfizer, unrelated to the submitted work. All other authors declare no competing interests.

Funding Information:
The study was funded by the NIHR Health Technology Assessment programme (reference 15/130/07). MJR was funded by an NIHR post-doctoral research fellowship (PDF-2014-07-013). ADH is supported by an NIHR senior investigator award (NIHR 200151). JB was supported by the National NIHR Applied Research Collaboration West at University Hospital Bristol NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The Best Emollients in Eczema study was hosted by Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Group and developed with support from UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration, a UK Clinical Research Collaboration registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research Clinical Trials Unit support funding, and is supported by NIHR Clinical Research Networks West of England, Wessex, and East Midlands. Thank you to all the children, parents, and general practitioner surgeries who took part in the study. We are also grateful to the trial steering committee members (Richard McManus, Ben Carter, Joanne Protheroe, Sariqa Wagley, and Andrew Moore) and data monitoring committee members (John Ingram, Catriona Keerie, and Chin Whybrew).

Funding Information:
The study was funded by the NIHR Health Technology Assessment programme (reference 15/130/07). MJR was funded by an NIHR post-doctoral research fellowship (PDF-2014-07-013). ADH is supported by an NIHR senior investigator award (NIHR 200151). JB was supported by the National NIHR Applied Research Collaboration West at University Hospital Bristol NHS Foundation Trust. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The Best Emollients in Eczema study was hosted by Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Group and developed with support from UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration, a UK Clinical Research Collaboration registered clinical trials unit which, as part of the Bristol Trials Centre, is in receipt of National Institute for Health Research Clinical Trials Unit support funding, and is supported by NIHR Clinical Research Networks West of England, Wessex, and East Midlands. Thank you to all the children, parents, and general practitioner surgeries who took part in the study. We are also grateful to the trial steering committee members (Richard McManus, Ben Carter, Joanne Protheroe, Sariqa Wagley, and Andrew Moore) and data monitoring committee members (John Ingram, Catriona Keerie, and Chin Whybrew).

Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Structured keywords

  • HEHP@Bristol
  • BEE

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