Multi-centre randomised controlled trial of ion-exchange water softeners for the treatment of atopic eczema in children (Softened Water Eczema Trial)

Completed

• Conditions: Atopic eczema; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN71423189
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 310

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.