Title: Choice Of Moisturiser in Eczema Treatment (COMET): A feasibility study of pragmatic, single blind, randomised clinical trial to compare the clinical and cost effectiveness of leave-on emollients in treatment of infant eczema in primary care
Funder: Department of Health (England)

Abstract: Background: Eczema is the most common inflammatory skin disease of childhood. It can have a significant impact on the quality of the affected child’s life and that of their family. The majority of children with eczema are diagnosed in infancy (under 3 years of age) and managed exclusively by their general practitioner (GP) with emollients for maintenance and topical corticosteroids (TCS) for “flares”. Emollients improve the hydration and comfort of the skin and are thought to reduce TCS use, which is important because prolonged/strong TCS application can cause irreversible side-effects (e.g. skin thinning). However, poor adherence to emollient therapy is a common cause of treatment failure. There are over 30 different emollients listed in the Children’s British National Formulary (cBNF) but despite their importance, there is a weak evidence to guide which should be used first or even how often. Lack of consistency between GPs can be confusing for parents; some emollients may be more likely to cause skin irritation than others; failure to prescribe the emollient most likely to be effective and acceptable to the family may result in repeat consultations or poorly treated eczema; and expensive emollients may be being prescribed which have no advantage over cheaper alternatives. More information on emollient effectiveness emerged as one of the top four priorities (shared by patients/carer and clinicians) in a recent prioritisation exercise of treatments for eczema. Aims: We want to determine the feasibility of a large trial to answer the research question “What is the most clinically and cost effective primary emollient to prescribe for infants with eczema?” A feasibility study is necessary because there are a number of key uncertainties, including: optimal means of patient recruitment; the choice of interventions; feasibility of long-term patient-reported data collection; and the primary outcome measure. In addition to establishing the feasibility of the definitive study, we will undertake important methodological work that will improve our understanding of past, and inform the development of future, studies of eczema treatment. Plan of investigation: Patients will be recruited via their general practitioners and followed-up for 3 months. Patient-reported data will be collected via daily diaries – we will explore the use of mobile phones to support this, through text reminders and the development a mobile phone “app”. A research nurse will conduct baseline and monthly follow-up visits, which will include clinical (Six Area Six Sign Atopic Dermatitis, SASSAD, and Three Item Severity, TIS, scores) and biophysical (skin hydration, corneometry) assessments of eczema severity. Analyses will be undertaken to compare objective with patient-reported outcomes; and to determine the minimal clinically important difference (MCID) for SASSAD and corneometry. Summary of patient and NHS benefit: At the end of the study, we will have established the feasibility of the main trial and produced valuable preliminary data on emollient acceptability and effectiveness. The methodological work will help doctors interpret the meaning of previous research that has measured the effectiveness of eczema treatments using SASSAD and corneometry, and hence promote rationale prescribing for patient benefit. The mobile phone app will be made available for use by other researchers seeking to obtain medium-term data on the efficacy of eczema treatments. In the definitive trial, we will be able to compare the clinical and cost effectiveness of the study emollients and secondary analyses will examine for evidence of a “steroid sparing” effect. An answer to the research question will improve the treatment of eczema, reduce the variation in prescribing seen, and bring cost benefits to the NHS and patients through reduced number of consultations and multiple prescriptions for partially-used emollients.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: SKIN