Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care

Abstract

ObjectivesTo determine the feasibility of a randomised controlled trial of ‘leave on’ emollients for children with eczema.DesignSingle-centre, pragmatic, 4-arm, observer-blinded, parallel, randomised feasibility trial.SettingGeneral practices in the UK.ParticipantsChildren with eczema aged 1 month to <5 years.Outcome measuresPrimary outcome—proportion of parents who reported use of the allocated study emollient every day for the duration of follow-up (12 weeks). Other feasibility outcomes—participant recruitment and retention, data collection and completeness and blinding of observers to allocation.InterventionsAveeno lotion, Diprobase cream, Doublebase gel, Hydromol ointment.Results197 children were recruited—107 by self-referral (mainly via practice mail-outs) and 90 by inconsultation (clinician consenting and randomising) pathways. Participants recruited inconsultation were younger, had more severe Patient-Oriented Eczema Measure scores and were more likely to withdraw than self-referrals. Parents of 20 (10%) of all the randomised participants reported using the allocated emollient daily for 84 days. The use of other non-study emollients was common. Completeness of data collected by parent-held daily diaries and at monthly study visits was good. Daily diaries were liked (81%) but mainly completed on paper rather than via electronic (‘app’) form. Major costs drivers were general practitioner consultations and eczema-related prescriptions. Observer unblinding was infrequent, and occurred at the baseline or first follow-up visit through accidental disclosure.ConclusionsIt is feasible in a primary care setting to recruit and randomise young children with eczema to emollients, follow them up and collect relevant trial data, while keeping observers blinded to their allocation. However, reported use of emollients (study and others) has design implications for future trials.Trial registration numberISRCTN21828118/EudraCT2013-003001-26.

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care

“…There is no standard definition of infected eczema, so we used pragmatic inclusion criteria based on clinical suspicion of infection. Included children were clearly experiencing flares in their eczema, considering that their mean baseline POEM scores were higher than those found in other ambulatory care studies (8.9 and 9.8 in COMET 23 and BATHE 24 studies respectively; unpublished data), there was a significant improvement in severity scores during the follow-up period in all groups, more than 90% had 1 or more "classical" signs of infection, and 70% had S. aureus isolated from baseline swabs. Fewer than one-third, however, had moderate to severe crusting, and only 1 in 10 had moderate to severe weeping, so it is possible that not all participants had actual infection.…”

Comparison of patient (POEM), observer (EASI, SASSAD, TIS) and corneometry measures of emollient effectiveness in children with eczema: findings from the COMET feasibility trial

“…Different methods are available to measure the water content of the outer layers of epidermis, and there are few studies comparing these approaches with the patient‐reported or clinical assessments in our study. Corneometry readings were collected in participants’ homes with variable temperature and humidity, which we measured and adjusted for in our analyses . However, the observed variability in readings may reflect other factors, such as time since bathing or application of emollient.…”

“…The corneometer was chosen over the measurement of TEWL primarily because of the portability and robustness of the instrument. While standardized procedures written in accordance with guidelines on biophysical skin measurements were followed, measurements were taken in participants’ homes under uncontrolled conditions. Skin hydration was analysed in a multivariate linear regression model adjusted for variations in room temperature and humidity .…”

“…While standardized procedures written in accordance with guidelines on biophysical skin measurements were followed, measurements were taken in participants’ homes under uncontrolled conditions. Skin hydration was analysed in a multivariate linear regression model adjusted for variations in room temperature and humidity . Skin hydration is reported in this article in arbitrary units from 0 (wet) to 100 (dry), so a lower score represents a more positive outcome.…”

Understanding economic evidence for the prevention and treatment of atopic eczema

“…also evaluated an educational support programme, which included the provision of an educational DVD and telephone support . Moisturizers or barrier creams were evaluated in six studies . Other preparations evaluated included fluticasone propionate ointment; topical prednicarbate; and some oral preparations, including montelukast, bacterial lysate, ciclosporin A and antibiotics (vs. an antibiotic cream) for infected eczema .…”