BACKGROUND: The aim of this study was to compare the efficacy and safety of a topical suspension of bacterial antigens for the management of recurrent eczema in children. MATERIAL/ METHODS:Eighty pediatric patients, aged between 2 and 6 years, with a history of recurrent external auditory eczema, were enrolled in this study. Congenital immune deficiencies, treatment with corticosteroids, immunostimulant or immunosuppressive agents in the past 6 months, and bronchopulmonary disease were considered as exclusion criteria. The patients were randomized to receive topical suspension of bacterial antigens (Lantigen B) (Group A) or placebo (physiological solution) (Group B). The efficacy parameters were evaluated before, at the end of, and one year after the beginning of the therapy. All the children underwent clinical examinations, blood test, skin prick tests (SPT), and clinical evaluation using the clinical score proposed by Rajka and Langeland, considering the intensity, extent, and course of lesions. RESULTS: In Group A, using the statistical Wilcoxon test, we saw an improvement in the clinical items measured. It is important to consider that the patients were allowed to receive concomitant medications to treat acute episodes, which may have partially contributed to the positive results obtained. CONCLUSIONS: A topical suspension of bacterial antigens was significantly more effective than placebo in the treatment of recurrent eczema in children.
RCT Entities:
BACKGROUND: The aim of this study was to compare the efficacy and safety of a topical suspension of bacterial antigens for the management of recurrent eczema in children. MATERIAL/ METHODS: Eighty pediatric patients, aged between 2 and 6 years, with a history of recurrent external auditory eczema, were enrolled in this study. Congenital immune deficiencies, treatment with corticosteroids, immunostimulant or immunosuppressive agents in the past 6 months, and bronchopulmonary disease were considered as exclusion criteria. The patients were randomized to receive topical suspension of bacterial antigens (Lantigen B) (Group A) or placebo (physiological solution) (Group B). The efficacy parameters were evaluated before, at the end of, and one year after the beginning of the therapy. All the children underwent clinical examinations, blood test, skin prick tests (SPT), and clinical evaluation using the clinical score proposed by Rajka and Langeland, considering the intensity, extent, and course of lesions. RESULTS: In Group A, using the statistical Wilcoxon test, we saw an improvement in the clinical items measured. It is important to consider that the patients were allowed to receive concomitant medications to treat acute episodes, which may have partially contributed to the positive results obtained. CONCLUSIONS: A topical suspension of bacterial antigens was significantly more effective than placebo in the treatment of recurrent eczema in children.
Authors: Susannah Mc George; Sanja Karanovic; David A Harrison; Anjna Rani; Andrew J Birnie; Fiona J Bath-Hextall; Jane C Ravenscroft; Hywel C Williams Journal: Cochrane Database Syst Rev Date: 2019-10-29