{Reference Type}: Clinical Trial, Phase III
{Title}: [Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis].
{Author}: Gómez-Moyano E;Hiraldo Gamero A;Vera Casaño Á;Crespo Erchiga V;González Enseñat MA;Vicente Villa MA;Zsolt Fradera I;Moreno Giménez JC;
{Journal}: Rev Iberoam Micol
{Volume}: 32
{Issue}: 3
{Year}: Jul-Sep 2015
{Factor}: 1.385
{DOI}: 10.1016/j.riam.2014.04.002
{Abstract}: <B>BACKGROUND: </B>There is scarce information on the use of ciclopirox olamine in children.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.