Three hundred children are being recruited for a clinical trial to establish whether or not specialist silk clothing really does help in the treatment of eczema.
The £1m CLOTHES trial — Clothing for the relief of Eczema Symptoms — is being led by Professor Kim Thomas from the Centre of Evidence Based Dermatology at The University of Nottingham. The trial has been funded by National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme and is being co-ordinated from the Nottingham Clinical Trials Unit. Two clothing distributors have donated the clothing for the trial.
Professor Thomas said: "There have been some 'impressive' claims recently promoting specialist silk clothing as a new treatment option for people with eczema. However, it is still unclear if these garments really do provide additional benefits for patients. We are carrying out the first large-scale independent, randomised controlled trial of silk clothing for the management of eczema in children to establish whether or not these new products live up to the claims that are currently being made."
Recruitment began in November and will continue for 18 months. Children, between the age of one and 15, are needed to volunteer from Nottingham, Cambridge, north London, Portsmouth and the Isle of Wight.
Putting clothing to a fair test
The trial will compare the use of silk clothing plus normal eczema care, to normal eczema care alone. Children enrolled in the study will be put into one of two groups. The first group will receive three sets of silk underwear — this will be either a bodysuit and leggings, or vest and leggings depending on the child's age. The children will be asked to wear the clothing underneath their normal clothes for six months. Children who do not receive the clothing straight away will be given the clothing to try for themselves for two months after the first six months of the trial has finished. Throughout the trial all of the children will be free to continue with their usual eczema treatments, such as moisturisers and topical steroids.
Each child will be enrolled in the trial for eight months and will be asked to attend their local recruiting hospital on four different occasions throughout the trial period. Parents will be asked to complete a weekly questionnaire at home so that they can track how the eczema has been and how often the clothing has been worn.
Large scale trial with practical results
If this research can show that these garments provide additional benefits for patients, then this would be an important finding, and many eczema sufferers could benefit. Equally, if the research shows that the clothes provide no useful benefit, then patients and the NHS can save money by not using treatments that have been shown to be ineffective.
Professor Thomas said: "Most treatments of eczema only suppress the condition and may have side-effects. Silk clothing, which is comfortable to wear, is thought to have protective and antimicrobial properties. However, existing research evidence is limited to a few small studies. This research team plans to work with 300 children to see if the clothing really does help patients with eczema. A cost-effectiveness analysis will also be conducted to see if the garments represent value for money to the NHS and to families."
The trial brings together a team of experts from across the country. The universities involved are: The University of Nottingham, Portsmouth University, the University of East Anglia, Hull University and the University of Dundee. There are six NHS Trusts taking part in the study — Nottingham University Hospitals NHS Trust, Derby Hospitals NHS Foundation Trust, Barnet and Chase Farm Hospitals NHS Trust, Cambridge University Hospitals Foundation Trust, Isle of Wight NHS Trust and Portsmouth Hospitals NHS Trust.
The clothing has been donated by Espere Healthcare Ltd and DreamSkin Health Ltd.
Are you eligible?
If you think your child may be eligible to participate please contact the trial team on 0115 8844938 or [email protected] The website address is www.nottingham.ac.uk/clothes