Estudio fase III de la seguridad y la eficacia de ciclopirox olamina crema en niños afectados de dermatomicosis / Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis

Antecedentes. La información disponible sobre el uso de ciclopirox olamina en niños es limitada. Objetivos. El objetivo de este estudio fue evaluar la seguridad y eficacia de ciclopirox olamina crema al 1% en el tratamiento de la dermatomicosis en pacientes pediátricos. Métodos. Ensayo clínico fase iii multicéntrico, no controlado y abierto en pacientes de entre 3 meses y 9 años de edad diagnosticados de dermatomicosis mediante microscopía directa y cultivo, y tratados con ciclopirox olamina crema al 1% durante 28 días. Las evaluaciones clínicas y micológicas fueron realizadas antes del inicio del tratamiento, a los 7, 14 y 28 días de su inicio, y a los 28 días tras la finalización del mismo. Resultados. Se incluyeron 21 pacientes con una media de edad de 2,7 años (rango 3 meses-9 años). La localización más frecuente de la micosis fue la ingle (62%), y el agente causal más común Candida spp. (71%). El 62% de los pacientes no presentó ningún acontecimiento adverso; se notificaron acontecimientos adversos leves o moderados y únicamente uno, una dermatitis irritativa, se relacionó con el tratamiento. La seguridad global fue excelente en el 95% de los casos, y buena en el 5%. Tras la primera semana de tratamiento, 12 de 13 (92%) pacientes mostraron mejoría clínica, y en 5 de 7 (71%) se constató una eficacia clínica y micológica favorable. Al final del tratamiento, la curación clínica se observó en 7 de 9 (78%) pacientes. Ningún caso sufrió recidivas. Conclusiones. Ciclopirox olamina crema al 1% constituye un tratamiento seguro y efectivo de las micosis cutáneas superficiales, particularmente en infecciones por levaduras del género Candida, en niños de entre 3 meses y 10 años (AU)

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 (AU)

[Phase III study of the efficacy and safety of ciclopirox olamine cream in small children with dermatomycosis]. / Estudio fase III de la seguridad y la eficacia de ciclopirox olamina crema en niños afectados de dermatomicosis.

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.

Lesión nodular ulcerada / Ulcerated nodular lesion

No disponible

Micosis fungoide hipopigmentada / Hypopigmented micosis fungoides

No disponible

No disponible

Leishmaniasis cutánea asociada a leishmaniasis visceral en un paciente con virus de la inmunodeficiencia humana positivo / Cutaneous leishmaniasis associated with visceral leishmaniasis in a patient infected with human immunodeficiency virus

No disponible

No disponible