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

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eMediNexus    08 August 2020

The purpose of a study published in Revistaiberoamericana de micologia was to evaluate the efficacy and safety of ciclopirox olamine cream 1% in the treatment of dermatomycosis in pediatric patients.

This was a multicenter, non-randomized, open-label, phase III study, 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 the initiation of the therapy; at 7, 14 and 28 days after starting the treatment; as well as 28 days after its completion.

Overall, 21 patients were enrolled. The most frequent mycosis location was the inguinal region among 72%, while the most frequently isolated etiological agent was Candida spp. in 71%. The results revealed no seriousadverse events in 62% of the patients. Among the mild and moderate reported side effects, only one—irritative dermatitis—was speculated to be related to the treatment. Moreover, safety evaluation was excellent in 95% of the patients, and good in 5%. Additionally, after the first week of treatment, 92% of the patients showed a clinical improvement and 71% had both clinical and mycological improvements. Post treatment clinical cure was observed in 78% of the patients; there were no relapses.

Therefore, it was concluded that ciclopirox olamine cream 1% is a safe and feasible treatment optionfor superficial cutaneous mycotic infections, especially Candida spp. infection, in children aged 3 months to 10 years.

Source: Revistaiberoamericana de micologia. Jul-Sep 2015;32(3):164-9.doi:10.1016/j.riam.2014.04.002.

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