CLOTHES Trial – Clothing for the relief of Eczema Symptoms
Research type
Research Study
Full title
Randomised controlled trial of silk therapeutic clothing for the long-term management of eczema in children
IRAS ID
113708
Contact name
Kim Thomas
Contact email
Research summary
Eczema is a chronic, inflammatory skin condition that is common in childhood. Whilst most cases of eczema can be successfully treated with topical medications, many parents express concern at using these preparations and are keen to explore non-drug treatment options. It has long been understood that clothing can cause irritation to the skin, and current guidelines recommend the use of loose cotton clothing, and the avoidance of wool and other rough fibres next to the skin. New clothing products have become available in recent years, and these are now marketed as having beneficial effects in the treatment of eczema. The therapeutic silk garments included in this study are available on prescription through the NHS, but the trial evidence supporting their use is currently limited with trials being small and of too limited a duration to inform clinical practice. A randomised clinical study comparing 300 children aged between 1 and 15 years with moderate and severe eczema children is therefore planned. Children will be randomised into one of two groups – one to receive their standard eczema care for 6 months followed by standard care and clothing for the following 2 months, the other to receive their standard eczema care and clothing for the full 8 months of the study. They will be asked to visit clinic four times and to complete some on-line or postal questionnaires. The primary end point will be eczema severity over the first 6 months of the study measured by the Eczema Area and Severity Index (EASI) at baseline, 2, 4 and 6 months, measured by a research nurse blind to randomisation. There will also be an option to provide a small saliva sample to allow testing of whether children carrying a gene mutation are more likely to respond to the clothing. This will require additional consent.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0255
Date of REC Opinion
15 Jul 2013
REC opinion
Favourable Opinion