Eczema MedDRA version: 20.0 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 100000004858
Conditions
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children must: • be aged between 6 months and less than 12 years of age • have eczema diagnosed by an appropriately qualified healthcare professional (registered doctor, nurse or health visitor) • mild eczema or worse (POEM score>2) The person giving consent must: • have parental responsibility for the participant • be willing to use the randomly allocated emollient as the only leave-on emollient for 16 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 520 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Child: • known sensitivity to study emollients or their constituents • participating in another research study currently or in the last four months • any other known adverse medical or social circumstance that would make invitation to the study inappropriate (as determined by GP practice staff) The person giving consent: • unable to give informed consent • insufficient written English to complete outcome measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question in this study is, "Which is the most clinically effective primary emollient to use in children with eczema?" Therefore, the main objective is to compare the medium-term (16 weeks) effectiveness of the four study emollients in children with eczema with respect to patient-reported eczema symptoms.;Secondary Objective: The secondary objectives are to examine the medium (16 weeks) and long-term (52 weeks) effectiveness of the study emollients, their acceptability, adverse effects, as well as any impact on quality of life for the child and their family. In addition, specific objectives of the qualitative study are to understand and optimise recruitment processes; explore facilitators or barriers to study emollient use; explore carers’ and children’s experiences of study emollient use and their views about perceived effectiveness and/or acceptability of study emollients; and to contextualise the trial findings, as an aid to interpreting the results and their potential impact on clinical practice. ;Primary end point(s): The primary outcome is parent-reported eczema symptoms (POEM, measured weekly for 16 weeks).;Timepoint(s) of evaluation of this end point: For the primary analysis, we will use linear mixed models (weekly observations, level 1) nested within participants (level 2)) to explore whether there are differences in mean POEM scores between treatment groups. This approach allows incomplete cases (i.e. patients who did not complete all of their weekly scores) to contribute to the analysis. Therefore, all patients contributing at least one post-baseline observation will be included. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following secondary outcomes (time period) will be collected: • Parent-reported eczema symptoms (POEM, measured monthly for 52 weeks) • Eczema Area Severity Index (EASI) (assessment of eczema signs, by blinded assessor at 16 weeks) • Use of study emollient/other eczema treatments (daily use reported weekly for 16 weeks, then monthly until 12 months) • Parent satisfaction with emollient (at 16 weeks) • Adverse events (localised reactions – stinging, itching, burning sensation, worsening of eczema, tingling, redness/inflammation, swelling, dryness, pain, peeling of the skin, skin infection – and slips/falls, weekly for 16 weeks, then monthly until 52 weeks) Quality of life measures will be collected at baseline, weeks 6, 16 and 52 by means of participant questionnaires: • Disease-specific – child ADQoL; family – Dermatitis Family Impact questionnaire (DFI) • Generic – child: CHU-9D (currently validated for children aged 7 and over, with pilot versions for those aged 5-7 and additional guidance notes and validation questions for those under 5) With a view to carrying out economic analyses in the future, we will also collect data on personal costs related to eczema, healthcare consultations and prescription data. A separate health economic analysis plan will be developed.;Timepoint(s) of evaluation of this end point: The timepoints of evaluation for the secondary outcomes are given above, since the timepoints vary by most measures. | — |
Countries
United Kingdom
Contacts
Public ContactBirgit Whitman
University of Bristol
Outcome results
None listed