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Killed Mycobacterium vaccae suspension in children with moderate-to-severe atopic dermatitis: a randomized, double-blind, placebo-controlled trial

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Summary 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.
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Keywords: Mycobacterium vaccae; SASSAD score; atopic dermatitis; double blind; hygiene hypothesis; placebo-controlled trial; randomized

Document Type: Research Article

Affiliations: 1: Department of Dermatology, George Eliot Hospital, Nuneaton, UK, 2: Booth Hall Children's Hospital, Manchester, UK, 3: Clinical Hospital Split, Spinciceva, Croatia, 4: North London Clinical Studies Centre, Mount Vernon Hospital, Northwood, Middlesex, UK, 5: Cardiff University, Heath Park, Cardiff CF14 4XN, UK, 6: University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4HH, UK, 7: Southampton General Hospital, Southampton SO16 6YD, UK, 8: Leeds Foundation for Dermatological Research, Clinical Trials Unit, Dermatology Department, Leeds General Infirmary, Leeds LS1 3EX, UK, 9: Ninewells Hospital & Medical School, Dundee DD1 9SY, UK, 10: King George Hospital, Barley Lane, Goodmayes, Essex IG3 8YB, UK, 11: Great Ormond Street Hospital for Children NHS Trust, London WC1N 3JH, UK, 12: Skin Therapy Research Unit, St Thomas's Hospital, London SE1 7EH, UK and 13: Windeyer Institute for Medical Sciences, University College London, London WC1 T4JF, UK

Publication date: September 1, 2006

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