1. Why are you doing this study?
Eczema is a common skin problem that particularly affects young children. Whilst some people experience only mild symptoms, for others, their eczema can have a big impact on their life, with the misery of constant itching resulting in loss of sleep and time off school or work. We know that children with eczema also develop more food allergies, asthma and hayfever.
Since there is no known cure for eczema, finding a way to prevent it is particularly important.
2. What questions what the BEEP pilot trial designed to answer?
The main aim of the BEEP pilot trial was to assess whether parents were willing to take part in a trial of applying emollients to their baby from birth to 6 months of age.
All families were given advice on best practice skin care for their baby and half the families were advised to apply emollient at least daily to their baby until the age of 6 months. Babies were assessed by a dermatologist for signs of eczema at 6 months of age.
3. How many families took part?
A total of 124 families took part throughout the East Midlands, UK, and Portland, USA.
4. What were the main findings?
The BEEP pilot trial was very successful. It demonstrated that a large scale trial was possible and that the design of the trial was appropriate and acceptable to parents. The results also suggest that applying emollients to a baby’s skin from birth may be effective in preventing eczema.
Although this is an encouraging sign, this was a small pilot trial and so the results should be viewed with caution until the larger definitive trial is completed. This large BEEP trial (ISRCTN21528841) is now underway.
5. Why is this research important?
Since there is no known cure for eczema, finding a way to prevent it is particularly important. There are studies showing an association between loss-of-function filaggrin gene mutations and atopic eczema, and this has generated interest in the potential for enhancing the skin barrier to prevent the development of eczema.
It is known that emollients can reduce the incidence of flares of existing eczema and there is some evidence from uncontrolled studies that emollients may have a preventative effect against development of eczema. A definitive trial is needed but pilot work was needed before this could go ahead. The results of this pilot trial were used to support a successful bid to the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) for the main trial which will provide a definitive answer to whether emollients from birth can prevent eczema http://www.nets.nihr.ac.uk/projects/hta/126712.
6. How was the trial funded?