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

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

doi:10.1016/s2352-4642(22)00146-8

Cited by 25 publications

(9 citation statements)

References 28 publications

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“…The BEE trial summarized the findings from patient-completed questionnaires by symptom and emollient type, clearly demonstrating the frequency and nature of the adverse event. 44 This was similar to Angelova-Fischer et al but included a more extensive list of symptoms such as worsening of eczema, peeling of skin and swelling. 33 , 44 …”

Section: Discussionmentioning

confidence: 92%

“…It is therefore important that adverse events are accurately recorded and reported to improve clinical practice. Since running the searches, the Best Emollients for Eczema (BEE) trial has been published, 44 which reported that 37% of children experienced one or more adverse event, although (with the exception of stinging) this did not differ between lotions, creams, gels or ointments.…”

Section: Discussionmentioning

confidence: 99%

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How and what adverse events are reported and captured in randomized control trials of emollients in the treatment of eczema?

Emmett¹,

Allen

Crownshaw

et al. 2023

Clinical and Experimental Dermatology

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Background Emollients are universally recommended for atopic dermatitis/eczema (“eczema”), to improve the skin barrier and reduce symptoms. However, our knowledge of the frequency and nature of adverse effects associated with their use is limited. Objective We sought to determine how well adverse events are reported in randomised controlled trials (RCTs) of emollients for eczema. Methods Medline was searched from inception (1946) to May 2022. Inclusion criteria: RCTs of moisturisers or emollients used as a leave-on treatment (as the intervention or control) in adults or children with eczema. Exclusion criteria: non-RCTs; patients with other diagnoses included; use of emollient as bath additives, soap substitutes, or as preventative; not published in English. References of eligible papers were reviewed for any additional, relevant research. Data were extracted into an Excel spreadsheet and analysed descriptively. An assessment of study quality was carried out using the JBI tool for RCTs. Results From 369 potential papers, 35 papers (reporting on 34 studies) were included. Most research was conducted in research centres or hospitals (unclear in 33%). 89% reported collecting data on adverse events related to emollient treatment use but the methods used were poorly reported (40% unclear). Four papers used patient questionnaires/diaries. However, it was unclear how and what was collected as only two studies showed the questionnaires used. Conclusions Reporting of adverse events related to emollient use in trials of patients with eczema is poor and inconsistent. Agreement should be reached on how and what adverse events should be collected, to standardise reporting across studies.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 99%

How and what adverse events are reported and captured in randomized control trials of emollients in the treatment of eczema?

Emmett¹,

Allen

Crownshaw

et al. 2023

Clinical and Experimental Dermatology

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“…In a firm-sponsored study of 34 adults with dry skin, a moisturizer with physiological lipids showed superiority compared with one containing paraffin [ 10 ]. On the other hand, a large, randomized study found no difference in eczema severity in children with AD following 16 weeks of twice daily application of either lotion, cream, gel, or ointments [ 28 ]. It is reasonable to assume that another test moisturizer in a similar study set-up would result in a different result.…”

Section: Discussionmentioning

confidence: 99%

Stratum Corneum Lipids in Non-Lesional Atopic and Healthy Skin following Moisturizer Application: A Randomized Clinical Experiment

Ahlström,

Bjerre,

Ahlström

et al. 2024

Life

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Introduction: It is an international standard to recommend patients with atopic dermatitis (AD) to use moisturizers; however, little is known about their effect on lipids in the stratum corneum (SC). Methods: In this randomized clinical experiment of 30 Caucasian participants (15 with AD and 15 healthy controls), the superficial SC lipid profile was assessed through tape stripping non-lesional skin following treatment thrice daily for seven days with a moisturizer, and subsequently compared with untreated skin. Results: No discernible disparity in superficial SC lipid quantity was evident between the AD group and the control group. However, the SC lipid composition diverged significantly, with the AD group exhibiting diminished levels of long-chain EO CERs (p = 0.024) and elevated levels of short-chain C34 CERs (p = 0.025) compared to healthy skin. Moisturizer application significantly reduced the total SC lipids and all lipid subgroups in both groups. Within the AD group, a non-significant inclination towards an augmentation in EO CERs (p = 0.053) and reduction in C34 CERs (p = 0.073) was observed. Conclusion: The recent identification of distinctions in SC lipid composition between AD and healthy skin was substantiated by our findings. Topical moisturizer application, despite reducing overall total lipids, indicated a potential tendency towards a healthier lipid constitution in AD skin.

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“…In a large prospective trial of pediatric patients with mild atopic dermatitis, no difference was observed in AD severity as a function of emollient types applied (lotion, cream, gel, ointment), yet these results may have limited applicability to a diverse population, as 84% of study participants were White. Although there were not many adverse events reported, decreased stinging sensation was reported in those who applied ointment [12 ▪ ]. For those moisturizers targeted to infants, 90% of these products contained at least one contact dermatitis allergen included in the Allergic Contact Dermatitis Society's core allergen list, highlighting the importance of selecting moisturizers and topical products that may not contribute to potential allergic contact dermatitis in children with dry skin and AD [13 ▪ ].…”

Section: Adjunctive Treatmentmentioning

confidence: 99%

A practical approach to caring for atopic dermatitis in children

Bayer

2023

Current Opinion in Pediatrics

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Purpose of review Atopic dermatitis is a chronic, systemic disease with primary cutaneous clinical manifestations and is commonly attributed to an exaggerated Th2 inflammatory response. Recent research regarding risk factors, prevention, clinical features, and management of atopic dermatitis will be reviewed. Recent findings In the last decade, advances have been made in identifying the factors that either confer increased risk for or protection from atopic dermatitis and associated atopy. Progress has also been made in the clinical management of this disease. Promising biomarkers and therapeutically informative characteristics of this disease have been identified in young children with and without the presence of eczema, but much has yet to be elucidated. Progress has also been made in clarifying the advantages and disadvantages of respective medical managements, including but not limited to topical corticosteroids, topical calcineurin inhibitors, phototherapy, systemic immunosuppressants, and targeted immunotherapy. Given that medical management may show variable efficacy in a child, an optimized skin care regimen is of utmost importance as well. Summary Atopic dermatitis is a challenging, chronic systemic disease that incurs significant morbidity in affected children. Although management options have been somewhat disappointing in years past, promising results have been observed in recent advances in targeted immunotherapy.

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

Cited by 25 publications

References 28 publications

How and what adverse events are reported and captured in randomized control trials of emollients in the treatment of eczema?

How and what adverse events are reported and captured in randomized control trials of emollients in the treatment of eczema?

Stratum Corneum Lipids in Non-Lesional Atopic and Healthy Skin following Moisturizer Application: A Randomized Clinical Experiment

A practical approach to caring for atopic dermatitis in children

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