Atopic eczema Skin and Connective Tissue Diseases Atopic eczema
Conditions
Interventions
Ion-exchange water softener installed for 4 or 12 weeks. The research nurse is blinded as to intervention status.
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 6 months to 16 years at baseline, with eczema as defined by the UK refinement of the Hanifin and Rajka diagnostic criteria 14. 2. Eczema present at time of assessment (minimum Six Area Six Sign Atopic Dermatitis [SASSAD] score of 10). 3. Baseline water hardness of >200 mg/l of calcium carbonate. 4. Home suitable for the installation of a water softening device (as assessed by water engineer) 5. Property not > 5 storeys high
Exclusion criteria
Exclusion criteria: 1. Children who plan to be away from home for >21 days in total during the 16-week study period. This has been deemed necessary in order to ensure adequate exposure to the intervention. We will also aim to ensure children do not have a planned holiday in the 4 weeks prior to their 12 week assessment visit. 2. Children who have taken systemic medication (e.g. Cyclosporin A, methotrexate) or UV light for their eczema within the last 3 months because of their long lasting effects. 3. Children who have taken oral steroids within the last 4 weeks, or who, as a result of seeing a healthcare professional, have started a new treatment regimen for eczema within the last 4 weeks. 4. Families who already have a water treatment device installed, including ion-exchange softeners, polyphosphate dosing units or physical conditioners.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the active vs. standard treatment groups with regard to mean change in disease severity (SASSAD 5) at 12 weeks compared to baseline. SASSAD is an objective severity scale that is completed by the research nurse during follow-up appointments. It does not involve input from the patient in any way. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 14/01/10: 1. Difference between the groups in the proportion of time spent moving during the night . Movement will be captured for periods of one week at week 1 and week 12 and will be measured using accelerometers (Actiwatch™). These units are worn by the child in the same way as a wrist watch. This outcome has been included as an objective surrogate for sleep loss and itchiness (two of the defining features of eczema). Previous research has suggested that this is a suitable objective tool for assessing itch and further pilot work is currently underway to assess its suitability for use within this trial. 2. Difference in those who report a reasonable (=20%), good (>20% and =50%) or excellent (>50%) improvement in SASSAD score at 12 weeks. 3. Difference in Patient Oriented Eczema Measure (POEM) collected at baseline, weeks 4, 12 and 16. This scale is a well validated tool that has been developed to capture symptoms of importance to patients (rather than objective signs that are used in traditional severity scales, such as SASSAD). 4. Difference in the number of totally controlled weeks (TCW) and well controlled weeks (WCW) based on the number of days with eczema symptoms and the number of days that topical treatment is applied, up to the primary endpoint at 12 weeks. This outcome is based on a recent systematic review conducted by the applicants looking at ways of assessing long-term control for chronic conditions such as atopic eczema, asthma and rheumatoid arthritis. The terms TCW and WCW have been adopted for use by researchers in the field of asthma and appear to be a useful and intuitive means of capturing disease activity over time. 5. Difference in the mean change in the Dermatitis Family Impact (DFI) questionnaire at 12 weeks. This scale was chosen as an appropriate quality of life scale for the study for two reasons: a. The intervention involves the entire household, so a quality of life scale appropriate to the family unit se | — |
Countries
United Kingdom
Outcome results
None listed