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

Abstract

BACKGROUND:

There is scarce information on the use of ciclopirox olamine in children.

AIMS:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: 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
• Journal: Revista iberoamericana de micologia (Rev Iberoam Micol) 2015 Jul-Sep Vol. 32 Issue 3 Pg. 164-9 ISSN: 2173-9188 [Electronic] Spain
• Vernacular Title: Estudio fase III de la seguridad y la eficacia de ciclopirox olamina crema en niños afectados de dermatomicosis.
• PMID: 25728876 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Revista Iberoamericana de Micología. Published by Elsevier Espana. All rights reserved.

Chemical References

• Antifungal Agents
• Dosage Forms
• Pyridones
• Ciclopirox

Topics

• Antifungal Agents (therapeutic use)
• Child, Preschool
• Ciclopirox
• Dermatomycoses (drug therapy)
• Dosage Forms
• Female
• Humans
• Male
• Pyridones (therapeutic use)
• Treatment Outcome