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Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized,
J Berth-Jones1, P D Arkwright, D Marasovic
1Department of Dermatology, George Eliot Hospital, Nuneaton, UK. johnberthjones@aol.com
Background:
The hygiene hypothesis is often proposed to explain the high prevalence of atopy in the western world. Dysregulation of the immune system may result from inadequate exposure to micro-organisms such as mycobacteria. A small trial suggested that a killed extract of Mycobacterium vaccae ameliorates atopic dermatitis (AD).
Objectives:
To confirm in a large clinical trial whether killed M. vaccae ameliorates AD in 5-16-year-old children.
Methods:
This was a randomized, placebo-controlled, double-blind, multi-centre study of the effect of intradermal injection of killed M. vaccae (0.1 or 1 mg) on patients, aged 5-16, with moderate-to-severe AD. Patients were followed up for 24 weeks. The primary end point was the change in severity of AD at 12 weeks, assessed using the six area, six-sign, atopic dermatitis (SASSAD) score. Secondary end points included changes in disease extent, patient's global assessment and children's dermatology life quality index.
Results:
There were 166 patients randomized. The mean SASSAD score fell to a similar degree at week 12 in all treatment arms: from 33 to 24, (26%) in the high-dose group, from 30 to 23 (25%) in the low-dose group and from 36 to 27 (24%) in the placebo group (P>0.05). Secondary end points followed the same trend. Adverse events were generally those expected to occur in this population. Injection site reactions occurred in 32 patients at week 4.
Conclusions:
M. vaccae was no more effective than the placebo in ameliorating the severity of AD.
