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University of Southampton
School of Medicine
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Clinical Trial of an Eczema Vaccine
Volunteer adult eczema sufferers living within reach of
Southampton University are urgently needed for a clinical trial starting this summer. If you are interested
in learning more about the study, please visit the website at http://www.eczemastudy.co.uk/.
The
Department of Allergy and Inflammation Research at the University of Southampton is carrying out the
study. It will take place at the Royal South Hants Hospital, Southampton. Enzyme Potentiated Desensitisation
(EPD) is a low-dose allergy vaccine intended to deal with allergic causes of conditions such as asthma,
hay fever and eczema. In the case of eczema, by desensitising the sufferer to the allergy-promoting
substances underlying the condition, it is hoped to prevent the inflammation that causes eczema from
occurring in the first place thereby allow the skin to heal normally.
Enzyme Potentiated Desensitisation
The EPD vaccine combines the enzyme beta-glucuronidase (present naturally in the body) with minute doses
of allergens (allergy-causing substances), such as dust mites, pollens, fungal spores and food proteins.
Three tiny doses will be given by single injection at two-month intervals to desensitise the patient
to those substances. The volume injected is about the size of a small raindrop. The method is not new,
having been in use in several countries for 15-20 years. The safety record of the technique is excellent,
between a third and a half a million doses having been given without incident. The doses of each allergen
given are so tiny they are almost homoeopathic. In fact patients receiving allergy skin prick tests,
generally regarded as very safe, receive doses of allergens over 100,000 times greater than those contained
in a single EPD treatment.
A few years ago an audit of EPD desensitisation treatment undertaken
in the USA (see below) suggested that eczema patients appeared to do very well. However until a randomised
clinical trial (a trial of treatment in which patients do not know whether they are having real or dummy
treatment) has been undertaken doctors will not be able to fully trust these claims. To help us to decide
how big a treatment benefit might be expected, a preliminary audit study was undertaken at Southampton.
The case records of all 21 patients who commenced EPD treatment with a single UK physician between 1998
and 2000 were analysed, concentrating on the degree of improvement noted after three treatments had been
completed. Seven patients showed no improvement (or the record was inadequate), four were recorded as
either 'much better' or '25 to 50% better' five were recorded as '50 to 75% better' and five were recorded
as 'excellent' or 'clear'.
USA Audit
A much larger scale audit of EPD treatment in eczema
was carried out a few years ago in the USA. This study was undertaken under the auspices of the Great
Lakes College of Clinical Medicine and was supervised by the Federal Drugs Agency. In this audit, 636
eczema patients who had been treated with EPD were surveyed. 71% rated the response to EPD as good or
excellent with just 13% rating it as poor. However, whilst this audit data is most encouraging, taken
on its own is does not give 100% certain evidence for the benefit of the treatment. For example, it
is possible for an audit to exaggerate the percentage apparently gaining benefit from a treatment, if
those not benefiting withdraw after a few treatments and therefore contribute less information to the
audit.
To complete the study 40 volunteers are needed. Three-quarters will receive one of three
'active' treatments; one quarter will receive a 'placebo' treatment. Those given the placebo treatment
will later be offered active treatment if the study turns out positive.
Further Information
For
further information about the study, please visit the study website:
http://www.eczemastudy.co.uk/.
For further information about EPD treatment, please contact McEwen Laboratories:
Tel: 0118 984 1288
E-mail: m2.mcewen@pop3.hiway.co.uk
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