Dermatologic and Ocular DiseasesIntradermal administration of a killed Mycobacterium vaccae suspension (SRL 172) is associated with improvement in atopic dermatitis in children with moderate-to-severe disease☆
Section snippets
Patients and study design
This study was conducted as a single-center, randomized, double-blind, placebo-controlled trial. The children enrolled in the study, aged 5 to 18 years, attended the University Department of Child Health outpatient clinic at Booth Hall Children’s Hospital, a regional referral center for unusually severe or persistent atopic dermatitis. Sixty children with moderate-to-severe atopic dermatitis were initially considered for the study. Eight children and their parents declined to take part, 7 were
Baseline characteristics
The baseline characteristics of the children with atopic dermatitis who took part in the study are shown in Table I.
Characteristic Placebo SRL 172 P value No. 20 21 Age (y) 10 ± 4 9 ± 4 .3 Male patients, n (%) 12 (60) 6 (29) .04 White patients, n (%) 13 (65) 16 (76) .4 Surface area affected (%) 40 ± 30 38 ± 30 .8 Dermatitis score (0-300) 38 (22-86) 55 (19-69) .8 IgE 1000 kU/mL (≤0.1) 6.6 (1.7-19.7) 9.2 (0.6-15.2) .8 Blood eosinophil
Discussion
This randomized, double-blind, placebo-controlled study demonstrated that in the cohort of children studied, there was a significant reduction in the severity of their atopic dermatitis after a single intradermal injection of killed M vaccae suspension (SRL 172) without any major adverse effects. The lack of any placebo effect may relate to the relatively short duration of the trial and the objectivity of the assessment scores, especially the use of surface area affected by dermatitis as the
Acknowledgements
We thank Dr Leena Patel and Dr Carol Ewing for permission to use their patients in this study; Dr Kath. Bennett, CRC Paediatric and Familial Cancer Group, University of Manchester, for statistical advice; SR Pharma Ltd, London for providing SRL 172 and matching placebo; and Mrs Franscine Radavan and the pharmacy staff at Booth Hall Children’s Hospital for randomizing and allocating the treatments to the patients. Measurements of IgE levels were performed by the staff of the Department of
References (20)
The environmental predictors of allergic disease
J Allergy Clin Immunol
(2000)The role of lymphocytes in allergic disease
J Allergy Clin Immunol
(2000)The origin and erratic global spread of tuberculosis. How the past explains the present and is the key to the future
Clin Chest Med
(1997)- et al.
Randomised trial of intradermal Mycobacterial vaccae or intradermal hepatitis B immunisation in children with HIV infection
Vaccine
(1999) - et al.
Early BCG vaccination and development of atopy
Lancet
(1997) - et al.
Possible improved survival of patients with stage IV AJCC melanoma receiving SLR 172 immunotherapy: correlation with induction of increased levels of intracellular interleukin-2 in peripheral blood lymphocytes
Ann Oncol
(1999) - et al.
Epithelial-mesenchymal interactions in the pathogenesis of asthma
J Allergy Clin Immunol
(2000) Dendritic cells: unique leukocyte populations which control the primary immune response
Blood
(1997)Atopic dermatitis: new insights and opportunities for therapeutic intervention
J Allergy Clin Immunol
(2000)Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema
Lancet
(1998)
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Reprint requests: Peter D. Arkwright, MB, DPhil, Academic Unit of Child Health, University of Manchester, Booth Hall Children’s Hospital, Charlestown Rd, Manchester, M9 7AA, United Kingdom.