In the very first trial of its kind in the world over 300 families are being recruited to find out if water softeners can help in the treatment of childhood eczema.
The independent trial run by clinicians at The University of Nottingham has received funding of nearly £1million from the Department of Health's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. The study will focus on hard water areas in Nottingham and Leicester, Cambridge, London and the Isle of Wight.
The aim of the Soft Water Eczema Trial (SWET) is to discover whether eczema can be improved by deliberately softening all water used in the home — except at one tap in the kitchen which will supply mains water for drinking.
Families of eczema sufferers and some doctors have said that living in a hard water area may make eczema worse.
Recently a team of researchers at The University of Nottingham found that eczema is more common in primary school children living in hard water areas in the UK compared with children living in soft water areas. No one really knows why, but it could be because hard water contains high levels of calcium and magnesium, leading to increased use of soaps which can act as skin irritants.
Professor Hywel Williams and his research team at the Centre of Evidence Based Dermatology are running the trial. Professor Williams said: "I have wanted to do this study for many years as patients keep telling me that water softeners help their skin, but other people aren't so sure. Carrying out a proper randomised controlled trial will help us find the answer. If ion-exchange water softeners are found to improve the symptoms of eczema, this will be an extremely important finding for both patients and doctors. Many patients worry about the possible side effects of the usual treatments for eczema, so this would be a welcome addition to their treatment options."
The study is in the process of recruiting 310 children between the ages of 6 months and 16 years who have moderate to severe eczema. They need to live within travelling distance of the four main centres: Queen's Medical Centre in Nottingham; St Mary's Hospital in the Isle of Wight; Addenbrookes Hospital in Cambridge; and Chase Farm Hospital in Enfield. A centre is also planned for Leicester at the Leicester Royal Infirmary.
Each child takes part in the trial for a total of 16 weeks. They are randomised into two groups - one will have a water softener installed in their homes for 12 weeks, the other for 4 weeks. The study has a dedicated research nurse at each of the four main centres and each child needs to visit their allocated clinic on four occasions during the 16 weeks.
Trial Manager Karin Koller said: "The parents and children know which group they are in but the research nurses need to stay 'blinded' to the intervention in order not to bias their assessment of the children's eczema."
Selection into the trial depends on a number of factors, including whether the family live in the right area and if a water softener can be installed in their home.
Up to one fifth of all children of school age have eczema, along with about one in twelve of the adult population. The severity of the disease can vary. In mild forms the skin is dry, red and itchy, whist in more severe forms the skin can become broken, raw and bleeding. Eczema is not contagious and with treatment the inflammation of eczema can be reduced, though the skin will always be sensitive to flare-ups and need extra care and protection against dryness.
The water softener industry (through their representative body, the UK Water Treatment Association) - is closely involved in the development of the trial and a generic water softener has been specially produced for the study. The industry is meeting the costs of producing and installing water softener units. The study findings will be quite independent from any industry influence.
The trial will run until the end of next year and the results won't be known until the end of 2009 when all the information has been analysed.