E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Eczema is a dry and itchy skin condition. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
E.1.2 | Term | Atopic eczema |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is parent-reported eczema symptoms (POEM, measured weekly for 16 weeks). |
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E.5.1.1 | 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. |
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E.5.2 | 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. |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Aveeno lotion (cosmetic product) and Epaderm ointment (medical device) |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 75 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS (defined as 52 weeks after randomisation of last participant). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |