Barrier Enhancement Eczema Prevention (BEEP) feasibility study

Background

Although a lot of research has been carried out looking at treatments for eczema, much less has been done to see if eczema can be prevented from developing in the first place. The research that has been done has focussed mainly on avoiding potential allergens such as house dust mites and pets, or intervening in the diet of the mother or the baby. However, the benefits of these strategies to prevent eczema have yet to be proven.
There is evidence that defects in the proteins that help the skin to form an effective skin barrier, especially those associated with a gene called filaggrin, may contribute to the development of eczema. It is possible that being born with a defective skin barrier means that the skin is more likely to develop irritation and allergies.
Applying emollients (moisturisers) to babies with healthy skin could compensate for these defects and may prevent eczema developing. However, it is possible that rather than help prevent eczema, the emollients could cause allergens to stick to the skin and have the opposite effect. So we need a clinical trial to provide the answer. 

Aims

We will investigate whether applying lots of emollient (moisturiser) all over the baby at least once a day from birth (i.e. before there are any skin problems) can prevent the baby developing eczema.
However, this is a feasibility study and will NOT answer the question of whether emollient use will prevent eczema – this will be the purpose of a subsequent large scale randomised controlled trial (RCT). The large scale RCT will be time-consuming and expensive to conduct so it is very important that it is properly designed.
So the purpose of carrying out this feasibility study, which will mimic the main study, is to test how the main study will work and ask the participating families at the end what they thought of the study. So the families who take part will have the chance to shape the way the main study will look. 

Methods

We are inviting one hundred expectant mothers in the Midlands area to take part in this feasibility study. To be eligible, someone in the close family needs to have (or have had in the past):

• asthma, or
• eczema, or
• hay-fever

This is because babies born into families that have these health problems are more likely to develop eczema.
Families taking part in the study will be randomly divided into two groups as shown in figure 1. Half of the families will be given emollients to use from birth and the other half won’t (in line with current standard practice). Families in BOTH groups will be given advice on caring for their baby’s skin and allergy prevention advice, a free supply of soap substitute and advice to avoid using soaps and other cleansing products.

 

 

 

 

Families in the emollient (moisturiser) group will choose from three emollients of different textures: Sunflower Seed Oil, Doublebase or 50:50 white soft paraffin/ liquid paraffin.
Participating families will start the study as soon as possible after the birth of their baby. A member of the study team will keep in telephone contact throughout the 6 month study to check how things are going. The baby will then be seen by the research nurse after 3 and 6 months. An independent assessor (who doesn’t know whether the baby is in the emollient of control group) will assess the baby’s skin for signs of eczema. At the 3 month visit, the nurse will also take a sample of the baby’s saliva to test whether he or she has abnormalities in the filaggrin gene. If the family don’t wish this to be done, they can still take part in the study. At the end of the study, we will ask families to tell us what they thought of the study – the more they tell us, the better!
An overview of the study can be seen in figure 2.

 

How will we use the results of this feasibility study?

Firstly, the results of this feasibility study will tell us whether we can do a large study at all. Were enough families willing to take part? Were they able to apply the emollients as directed? If the answer is yes, then we can look at more details of the study to see where things could be improved. Was the choice of emollients acceptable? Were the nurses able to assess the babies for eczema without finding out which group the family are in? Did the collection of saliva samples for the filaggrin study work well? A full list of things we will look at can be seen in figure 3. The answers to these questions will provide the basis for the design of the main study.

 

In summary

There is some evidence to suggest that emollients may prevent the onset of eczema but good quality research in this area is lacking. The results of this feasibility study will provide the information needed to carry out a well-designed large main study which will investigate whether the use of emollients from birth can prevent eczema. 

Involvement of patients and the public

If you are interested in taking part in the BEEP study or would simply like to find out more, we would be pleased to hear from you. Please contact Joanne Chalmers, the BEEP Study Manager by

e-mail joanne.chalmers@nottingham.ac.uk
telephone 0115 823 2435
write to Centre of Evidence Based Dermatology, University of Nottingham, Kings Meadow Campus (Room A103), Lenton Lane, Nottingham, NG7 2NR or visit: www.nottingham.ac.uk/dermatology  

Publication of results

Once completed, a copy of the results of this feasibility study will be freely available to download from this website.

Progress to date

We expect to receive approval to start the study in November 2009. If you wish to register your interest at this stage, please contact us .