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J Dermatolog Treat ; 26(6): 541-7, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25909369

RESUMO

INTRODUCTION: Sodium cromoglicate (SCG), a chromone with anti-inflammatory, anti-itch and anti-allergic properties. We report a long-term study of a 4% aqueous solution of SCG in children with moderate to severe atopic dermatitis (AD). MATERIALS AND METHODS: Children aged 1 to 12 years with AD were entered into a 12-week randomised clinical trial (RCT), followed by 12 months open treatment with known 4% SCG emulsion (Altocrom®). Primary endpoint was change in SCORAD score. Secondary endpoints included symptom severity, Quality of Life, concomitant treatment usage, global assessments. RESULTS: One hundred and seventy-seven subjects entered, 118 treated with 4% SCG emulsion and 59 with vehicle: 128 completed 12 months in open study. SCORAD score reduced during RCT by -15.3 (-33%) on 4% SCG emulsion and -18.0 (-39%) on vehicle: p = 0.2331. After 12 months reduction was 56%. No secondary endpoint showed differences between treatments during RCT. Thirty-two subjects reported treatment related events during RCT and open trial. Eleven (7%) reported application site discomfort. Most were reported as mild and most resolved without intervention and the study drug was stopped in one case only. CONCLUSIONS: SCG 4% cutaneous emulsion was well tolerated in children treated for 15 months.


Assuntos
Antialérgicos/uso terapêutico , Cromolina Sódica/uso terapêutico , Dermatite Atópica/tratamento farmacológico , Qualidade de Vida , Anti-Inflamatórios/uso terapêutico , Criança , Pré-Escolar , Método Duplo-Cego , Feminino , Humanos , Lactente , Masculino , Prurido/tratamento farmacológico , Índice de Gravidade de Doença
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