1. How many trial participants do you need?
We are looking for 300 children to take part.
2. Is my child eligible to take part?
Children will need to have quite bad eczema – that is eczema that requires treatment with corticosteroid creams and that causes quite a lot of bother for your child.
They will also need to be aged between 1 and 15 years old.
3. How long will the study last for?
The study will last for three years from June 2013 to May 2016.
Each child will be enrolled in the study for eight months, during which time you will be asked to visit your local hospital four times. You will also be asked to fill in some questionnaires at home.
4. What treatments are you testing?
In recent years, silk clothing products have been developed for the management of eczema symptoms, but it has not yet been firmly established whether clothing provides measurable benefits for patients.
To decide whether silk clothing is a useful addition to the treatments currently available for children with eczema, we are testing two of the brands of silk clothing available on prescription for the management of eczema: DermaSilk® (Espère Healthcare Ltd) and DreamSkin® (DreamSkin Health Ltd).
All children involved in the study will also continue to use their usual eczema treatments.
5. Why are you only testing two brands of therapeutic silk garments?
The two brands of clothing used in the trial were chosen because the two brands of therapeutic silk clothing were the two available for prescription on the NHS at the time of trial set-up.
Since this time, the range of therapeutic silk-garments available to the consumer and on NHS prescription has grown (this now also includes Dermacea Ltd’s Skinnies™ Silk range).
At the present time, there is no accepted research to indicate that any silk garment products made for the management of eczema symptoms offer superior results over any others.
6. How is industry involved in this study?
The CLOTHES trial is an independent trial that has been funded through the National Institute for Health Research (NIHR) Health Technology Assessment Programme. The clothing being used in the trial has been donated by DreamSkin Health Ltd and Espère Healthcare Ltd, but these companies have had no involvement in the design, conduct or analysis of the trial results.
Whilst grateful to the companies for the donation of the garments, as independent researchers we maintain that impartiality is central to and necessary for the conduct of good medical research, and we do not endorse any of these garments over other similar products.
How to get involved
Harrison EF, Haines RH, Cowdell F, Sach TH, Dean T, Pollock I, Burrows NP, Buckley H, Batchelor J, Williams HC, Lawton S, Brown SJ, Bradshaw LE, Ahmed A, Montgomery AA, Mitchell EJ, Thomas KS.
A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.
Trials. 2015 Sep 2;16(1):390. doi: 10.1186/s13063-015-0921-9.
Recruitment to the CLOTHES study is now closed as the trial has reached its target for participants.
BBC radio interview with Amina Ahmed and Prof Kim Thomas - 15 January 2014
Study to test 'silk'benefits for eczema patients - BBC news report January 2014
Is silk the right road for eczema treatment? - Press release January 2014
National Eczema Society Exchange Magazine article -November 2013
Award for the CLOTHES trial featured in the Times Higher Education - 18th July 2013