Emollient bath additives for the treatment of childhood eczema (BATHE): multi-centre pragmatic parallel group randomised controlled trial of clinical and cost-effectiveness

Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean Baseline POEM was 9.5 (s.d. 5.7) in the bath additives group and 10.1 (s.d. 5.8) in the no bath additives group. The mean POEM over the 16-week period was 7.5 (s.d. 6.0) in the bath additives group and 8.4 (6.0) in the no bath additives group. There was no statistically significant difference in weekly POEM scores between groups over 16 weeks. After controlling for baseline severity and confounders (ethnicity, topical corticosteroid use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% CI -0.27 to 1.10), below the published minimal clinically important difference for POEM of 3 points. There was no difference between groups in secondary outcomes, economic outcomes or in adverse effects. Conclusions: This trial found no evidence of clinical benefit from including emollient bath additives in the standard management of childhood eczema. Further research is needed into optimal regimens for leave-on emollient and use of soap substitutes for children with eczema

Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care: Experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema)

Background Patient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks. Methods The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the seven-item Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with 10 participants. Interviews were audio-recorded, transcribed and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems. Results Four hundred and eighty-two participants were recruited to the trial and 429 opted to complete measures online (89.0%). Data were collected online for 83% of time points over the 16-week period and there was no association between socio-demographic characteristics and data completeness. Two hundred and six (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (SD 4.2). Interviewees said that they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child’s eczema changed weekly. Whilst some interviewees spoke of weekly questionnaires as onerous, others said that they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection. Conclusions Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16-week period

Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care:experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema)

Background: Patient‐reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing‐remitting conditions such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks.Methods: The objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the 7‐item Patient‐Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with ten participants. Interviews were audio‐recorded, transcribed, and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems.Results: 482 participants were recruited to the trial and 429 opted to complete measures online(89.0%). Data were collected online for 83% of timepoints over the 16 week period and there was no association between socio‐demographic characteristics and data completeness. 206 (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (s.d 4.2). Interviewees said they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child’s eczema changed weekly. While some interviewees spoke of weekly questionnaires as onerous, others said they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection.Conclusions: Amongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16 week period.Trial registration number: ISRCTN84102309, Registered on 9/12/201

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

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. Funding: National Institute for Health and Care Research

Adding emollient bath additives to standard eczema management for children with eczema:the BATHE RCT

Background Childhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness. Objectives To determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema. Design Pragmatic, randomised, open-label, multicentre superiority trial with two parallel groups. Setting Ninety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically. Participants Children aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation. Interventions The intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required. Main outcome measures The primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding. Results From December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group, n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping. Limitations Simple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups. Conclusion This trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema

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

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. Scientific summary Background Eczema (also called atopic eczema/dermatitis) is a common condition that usually first appears in early childhood. It is characterised by dry, itchy skin. Emollients are recommended for all patients, used as a ‘leave-on’ treatment to add and help retain moisture in the skin. For all but the mildest disease, they are used in combination with topical anti-inflammatory (topical corticosteroids or calcineurin inhibitors) to treat and prevent eczema flare-ups. Despite the accepted importance of emollients in treating the dry skin of eczema, there is limited evidence to guide prescribers and users on what types to use. In previous research, parents/carers (hereafter, parents) of children with eczema have spoken of a ‘trial and error’ approach to finding an emollient that suits them and their child, with the attendant frustration, waste and costs to both users and the health service. Objectives We sought to: compare the effectiveness and acceptability of four commonly used types of emollients (lotion, cream, gel and ointment) in the treatment of childhood eczema explore carers’ and children’s experiences of study emollient use and their views about perceived effectiveness and/or acceptability of study emollients. Methods We recruited children with eczema via general practitioners’ (GPs’) surgeries based in three centres (West of England, Wessex and East Midlands). To be eligible, children had to be aged between 6 months and 12 years and to have at least a mild form of disease, and parents had to be willing to be randomly allocated to any of the types as their main emollient. Children with a known sensitivity to study emollients or their constituents were excluded. Participants were randomised to lotion, cream, gel or ointment groups in a 1 : 1 : 1 : 1 manner, stratified by centre and minimised by baseline eczema severity as determined by the Patient Orientated Eczema Measure (POEM) score [mild (3–7 points) vs. moderate/severe (≥ 8 points)] and participant age (< 2 years vs. ≥ 2 years). Participants received their allocated type of emollient via their GP, who prescribed products on their local formulary that were study approved. All study emollients were paraffin based and none contained antimicrobials or urea. Study lotions contained glycerol [Cetraben (Thornton & Ross Ltd, Huddersfield, UK), Diprobase (Bayer UK Ltd, Reading, UK), QV (QV Skincare, Melbourne, VIC, Australia)], study creams had no humectant or lanolin [AproDerm (Fontus Health, Walsall, UK), Aquamax (Intrapharm Laboratories, Maidenhead, UK), Diprobase, Epimax (Aspire Pharma, Petersfield, UK), Zerobase (Thornton & Ross Ltd, Huddersfield, UK)], gels did not contain povidine [AproDerm (Fontus Health, Walsall, UK), Doublebase (Diomed Developments, Hitchin, UK), Isomol (Aspire Pharma, Petersfield, UK), MyriBase (Penlan Healthcare,Weybridge, UK) and Zerodouble (Thornton & Ross Ltd, Huddersfield, UK)] and study ointments had no additives (Diprobase, Emulsifying, Paraffin White soft, Paraffin Yellow soft ointment, White soft/Liquid paraffin 50/50). Participants were asked to use their study emollient as their only leave-on treatment for the first 16 weeks; thereafter, they were free to change. However, if they had problems with or disliked their study emollient, they could stop it and seek an alternative from their GP. Participants’ skin was assessed using the Eczema Area Severity Index (EASI) at baseline and at 16 weeks by a researcher masked to treatment allocation. Other data were collected by self-completed questionnaires weekly (first 16 weeks) and then 4-weekly (until 52 weeks). The primary outcome was eczema symptoms measured using the POEM over 16 weeks. We sought to recruit 520 children to detect a difference of 3.0 points in POEM scores between any two groups with 90% power and a significance level of 0.05, allowing for 20% loss to follow-up and multiple comparison testing. We conducted semistructured interviews with parents and older children at around 4 weeks and 16 weeks after randomisation, sampling on the characteristics of the children. The interviews were conducted face to face and by telephone, informed by a topic guide that was revised during the course of the study. Interviews were audio-recorded and transcribed verbatim. Analysis was thematic and carried out alongside data collection, which stopped once saturation was reached. Ethics approval was granted by the NHS Research Ethics Committee (South West – Central Bristol Research Ethics Committee 17/SW/0089). Results Between January 2018 and October 2019, 78 GP surgeries sent 9437 invitations to potentially eligible children. Expressions of interest were received from 910 parents, and 550 children attended a baseline visit, were eligible and enrolled. At baseline, the characteristics of participants were balanced except for sex, as there were more girls in the cream group (55%) than in the gel group (40%). Most children were white (86.0%), with a median age of 4 years (interquartile range 2–8 years) and moderate severity eczema (mean POEM score 9.32 points; standard deviation 5.46 points). Creams (94.5%) were most likely to have been used before, followed by ointments (66%), lotions (63.0%) and gels (25.0%). Participants were randomised to receive lotion (n = 137), cream (n = 140), gel (n = 135) or ointment (n = 138), with prescriptions issued by their GP. The median number of days between randomisation and reported first use of emollient was 4 days (interquartile range 3–7 days), with 80% reporting first use within 7 days of randomisation. There were 29 withdrawals (24 in the first 16 weeks). A total of 95% of participants provided at least one post-baseline POEM score and, therefore, were included in the primary outcome analysis. The researcher undertaking the EASI assessment identified the correct allocation in seven participants. There was no difference in the primary outcome (repeated-measures analysis of weekly POEM scores over the first 16 weeks) between the different groups (global p = 0.765). The adjusted differences in mean POEM scores [95% confidence interval (CI)] for pairwise comparisons were as follows: lotion versus cream 0.42 (95% CI –0.48 to 1.32; p = 0.360); lotion versus gel 0.17 (95% CI –0.75 to 1.09; p = 0.718); lotion versus ointment –0.01 (95% CI –0.93 to 0.91; p = 0.983); cream versus gel –0.25 (95% CI –1.15 to 0.65; p = 0.586); cream versus ointment –0.43 (95% CI –1.34 to 0.48; p = 0.354); and gel versus ointment –0.18 (95% CI –1.11 to 0.75; p = 0.704). Adjusting for sex imbalance at baseline and imputing missing data using multiple imputation did not meaningfully alter these results. There was no evidence of a difference in mean POEM scores between treatment groups or in any of the pairwise comparisons in first 16 weeks in ‘per-protocol’ analysis (p = 0.238) or over the 52 weeks (p = 0.909). There was no evidence of effect modification in prespecified subgroup analyses by parent prior emollient expectation (p = 0.935), participant age (p = 0.343), participant eczema severity (p = 0.042), or UK diagnostic criteria for atopic dermatitis (p = 0.291). No differences between groups were seen in the following secondary outcomes at 16 weeks (or 52 weeks, if also collected): EASI scores, Atopic Dermatitis Quality of Life scores, Child Health Utility 9-Dimension scores, Dermatitis Family Impact scores and well-controlled weeks. During the first 16 weeks, median reported weekly use of the allocated emollient appeared to be higher in the lotion and cream groups (6 days per week) and lower in the gel (5 days) and ointment (3 days) groups, but this difference in usage was not statistically significant (p = 0.481). Similarly, there was no difference between groups in median reported daily use of non-allocated emollient or topical corticosteroids. Overall satisfaction was highest with lotions and gels (67.3% and 64.5% very or mostly satisfied, respectively) and dissatisfaction was highest with creams and ointments (34.2% and 40.4% dissatisfied or very dissatisfied, respectively) (p = 0.003). Overall, 37% of participants reported at least one adverse reaction, the most common being ‘application site reactions’ (e.g. worsening of eczema). There was no evidence that the proportion of children reporting adverse reactions in the first 16 weeks of follow-up differed by treatment group (p = 0.794). There were no significant adverse events. In the nested qualitative study, 44 parents were interviewed, 20 at both weeks 4 and 24 (including five repeat interviews at week 16). Children took part in 25 interviews. Participants judged the effectiveness of study emollients by comparing them with others they had used in the past (i.e. the perceived hydrating action of the emollient, skin feel after application, skin symptoms and appearance, the number of flare-ups, and the need for topical corticosteroid use). Other factors identified as affecting effectiveness were weather and the frequency and quantity of emollient application. Acceptability was usually considered alongside or as part of the effectiveness of an emollient. Characteristics of the emollients that participants considered were how it felt on the skin, ease of application and absorbency, with smell being less important. In terms of containers, participants favoured pumps and squeezer bottles for practical reasons, including older child being able to self-apply. Many participants in the lotion and gel groups reported ease of application but felt that these types of emollients had to be used more often, and there was a perception that they ‘maintained’ rather than improved the skin. Although participants using study creams and study ointment were more likely to report improvements, opinions about their acceptability were more divergent. Problems were reported with all types of emollients. At 16 weeks, there was no clear pattern or differentiation between the emollient types in terms of continued use over and above the factors listed above. Parents of children with very dry and/or rough skin tended to prefer an emollient with a thicker consistency, such as a cream or an ointment. Age was also reported to influence emollient use: application may be easier/more frequent in younger children, accompanying nappy changes, and more difficult in older children as they become more independent and attend school. Some participants thought that their child’s eczema and the effectiveness of their emollient was related to their ethnicity. Changes in behaviour and knowledge were reported as a result of taking part in the trial. For some, the regular study questionnaires had reminded them to apply their emollient regularly. Others reported persisting more with one treatment or that the emollient information sheet had improved their knowledge of eczema management. Conclusions No one type of emollient was found to be superior, although these findings may not apply to children from more ethnically diverse backgrounds. Parents and children should be made aware that application site reactions are common; persistence may be required to find an emollient that works for them; and preferences may change with time, season and body site. We have also demonstrated the need for choice and education around the use of emollients for the treatment of eczema in children. Without this, emollients may be applied incorrectly or not as frequently as prescribed. Most children with eczema will need, in addition to their emollient, a topical anti-inflammatory treatment (usually corticosteroids) appropriate to the site and severity of their eczema to get, and keep, control of their condition. Guidelines should advocate for, and formularies support, a range of emollients, with lotions, creams, gels and ointments all available. Prescribers and pharmacists have an important role in ensuring that families are aware of the different emollients available, to support them in selecting a type most likely to suit them and to advise on optimal use. Verbal advice could be accompanied by written or online information (including videos) on the role of emollients and how to use them, perhaps accompanied by a planned review at the end of an agreed trial period. Future research could evaluate a decision aid to support parents and clinicians in deciding which type of emollient to try first and the clinical effectiveness and cost-effectiveness of providing ‘tester pots’ of each type of emollient to try before selecting their preferred emollient. Further trials may be appropriate to compare emollients in more ethnically diverse populations and of different types not evaluated in this study, for example ointments with emulsifiers and humectant-containing, plant-based and ‘novel’ emollients, including those designed to alter the skin microbiome. Research in this field would benefit from an internationally agreed system of classifying different emollients and a common approach to measuring and reporting treatment use. Finally, further research is needed to determine how emollients best fit into an overall package of eczema care, which includes frequency of use, bathing, use of other topical treatments and avoidance of triggers. 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