[Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis]

Autor: Elisabeth, Gómez-Moyano, Alicia, Hiraldo Gamero, Ángel, Vera Casaño, Vicente, Crespo Erchiga, M Antonia, González Enseñat, M Asunción, Vicente Villa, Ilonka, Zsolt Fradera, José Carlos, Moreno Giménez
Rok vydání: 2013
Předmět:
Zdroj: Revista iberoamericana de micologia. 32(3)
ISSN: 2173-9188
Popis: There is scarce information on the use of ciclopirox olamine in children.The aim of this study was to evaluate the efficacy and safety of ciclopirox olamine cream 1% for the treatment of dermatomycosis in pediatric patients.A multicenter, non-randomized, open-label, phase iii study was conducted on patients aged 3 months to 9 years diagnosed with dermatomycosis confirmed by direct microscopy and culture, and treated with ciclopirox olamine cream 1% for 28 days. Clinical and microbiological evaluations were performed before starting the treatment therapy, at 7, 14 and 28 days after starting the treatment, and 28 days after its completion.Twenty-one patients with a median age of 2.7 years (range 3 months-9 years) were included. The most frequent mycosis location was the inguinal region (72%). The most frequently isolated etiological agent was Candida spp. (71%). No adverse events were reported in 62% of the patients. Among the mild and moderate reported adverse events, only one, irritative dermatitis, was considered as possibly related to the treatment. Safety evaluation was excellent in 95% of the patients, and good in 5%. After the first week of treatment, 12 patients out of 13 (92%) showed a clinical improvement, and 5 out of 7 (71%) had both clinical and mycological improvements. At the end of the treatment, clinical cure was observed in 7 out of 9 patients (78%). No relapses occurred.Ciclopirox olamine cream 1% is a safe and feasible treatment for superficial cutaneous mycotic infections, especially Candida spp. infection, in children aged between 3 months and 10 years.
Databáze: OpenAIRE