[Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis].
BACKGROUND
There is scarce information on the use of ciclopirox olamine in children.


OBJECTIVE
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.
Servicio de Dermatología, Hospital Regional Universitario de Málaga, Málaga, España.
Elisabeth
E
Gómez-Moyano
Servicio de Dermatología, Hospital Regional Universitario de Málaga, Málaga, España.
Alicia
A
Hiraldo Gamero
Servicio de Dermatología, Hospital Regional Universitario de Málaga, Málaga, España.
Ángel
Á
Vera Casaño
Servicio de Dermatología, Hospital Regional Universitario de Málaga, Málaga, España.
Vicente
V
Crespo Erchiga
Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.
M Antonia
MA
González Enseñat
Servicio de Dermatología, Hospital Sant Joan de Déu, Barcelona, España.
M Asunción
MA
Vicente Villa
Departamento médico, Laboratorios Ferrer, S. A., Barcelona, España.
Ilonka
I
Zsolt Fradera
Servicio de Dermatología, Hospital Universitario Reina Sofía, Córdoba, España. Electronic address: md1mogij@uco.es.
José Carlos
JC
Moreno Giménez
D000935:Antifungal Agents / Q000627:therapeutic use*; D002675:Child, Preschool; D000077768:Ciclopirox; D003881:Dermatomycoses / Q000188:drug therapy*; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D011728:Pyridones / Q000627:therapeutic use*; D016896:Treatment Outcome
D000935:Antifungal Agents; D004304:Dosage Forms; D011728:Pyridones; D000077768:Ciclopirox
Antifungal treatment; Children; Ciclopirox olamina; Ciclopirox olamine; Dermatomicosis; Dermatomycosis; Niños; Safety; Seguridad; Tratamiento antifúngico