Best Emollients for Eczema trial - comparing emollients (emollient) commonly used for childhood eczema
Last edited 09/2022 and last reviewed 09/2022
Best Emollients for Eczema (BEE) trial - comparing emollients commonly used for childhood eczema
The Best Emollients for Eczema trial compared the clinical effectiveness and safety in childhood eczema of the four main emollient types:
- lotions,
- creams,
- gels,
- ointments
Methodology:
- 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
- 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
Study results:
- 12417 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)
- 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)
- 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)
- result remained unchanged following multiple imputation, sensitivity, and subgroup analyses
- 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)
Study authors concluded:
- there was no difference in effectiveness between the four main types of emollients for childhood eczema
A qualitative subset analysis was undertaken (nested qualitative study analysis) of the Best Emollients for Eczema trial (2)
- aim was to identify parents' and children's experiences of emollient use, and how they evaluated the effectiveness and acceptability of the four emollient types
- show that no emollient types were identified by the interviewees as either more effective or more acceptable than any other, and participants’ responses varied across all four emollient types
- effectiveness was prioritised over acceptability in shaping decisions about emollient use, although acceptability was also important and came to the fore when effectiveness was on a similar level as previously used emollients
- thickness and absorbency were key considerations in how emollients were evaluated
- thicker emollients were liked because of their 'protective' and long-lasting qualities, but tended to affect clothing and were difficult to apply
- lighter emollients absorbed into the skin, which for some highlighted moisturising capability but for others indicated a lack of 'protection'
- containers
- participants highlighted how containers effected acceptability, with pumps being preferred over tubs
- findings emphasised that emollients are not "all the same" with respect to acceptability
- shows that no one emollient will suit all children with eczema and supports the offer of a wide choice of emollients for families
Detailed summaries of the trial are linked here
Reference:
- Ridd MJ, Santer M, MacNeill SJ, Sanderson E, Wells S, Webb D, Banks J, Sutton E, Roberts A, Liddiard L, Wilkins Z, Clayton J, Garfield K, Barrett TJ, Lane JA, Baxter H, Howells L, Taylor J, Hay AD, Williams HC, Thomas KS. Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial. Lancet Child Adolesc Health.
- Sutton E, Shaw AR, Ridd MJ, Santer M, Roberts A, Baxter H, Williams HC, Banks J. How parents and children evaluate emollients for childhood eczema: a qualitative study. Br J Gen Pract. 2022 May 26;72(719):e390-e397