[Randomised clinical trial to evaluate the efficacy and safety of a new pediculicide made with saponified olive oil in the eradication of Pediculus humanus capitis]. / Ensayo clínico aleatorizado para evaluar la eficacia y seguridad en la erradicación del Pediculus humanus capitis de un nuevo pediculicida elaborado con aceite de oliva saponificado.

INTRODUCTION: The aim of the study was to evaluate the efficacy and safety of a new pediculicide in the eradication of Pediculus humanus capitis infestation. MATERIAL AND METHODS: A randomised clinical trial was designed, in which children aged between 5 and 15 years diagnosed with pediculosis were selected. Treatment was administered on days 1 and 7 after selection, and they were evaluated in 4 visits (day 2, 7, 9, and 14). The product under evaluation with saponified olive oil was Inex Pediculicide Soap®, which was compared with Paranix®, with a similar mechanism of action. The primary efficacy endpoint was the eradication of the parasite by day 14 (louse-free rate), using an intention to treat analysis. RESULTS: Six paediatricians from 5 Primary Health Care centres in the Community of Madrid (Spain) and one private clinic participated in the study. A total of 45 children were included, of which 75.6% were girls (n=34). The mean age was 7.1 years (95% CI 6.3-7.9). The large majority (80%) were middle class, and 82.2% had a history of previous pediculosis. The efficacy at 14 days was 76.2% (95% CI 52.8-91.8) in the group treated with Inex Pediculicide Soap® group, and 79.2% (95% CI 57.9-92.9) in Paranix® group (NNT=33.3). No adverse effects were observed with treatment. CONCLUSIONS: The 2 products were effective and safe in the eradication therapy Pediculus humanus capitis, with no statistical differences.

Ensayo clínico aleatorizado para evaluar la eficacia y seguridad en la erradicación del Pediculus humanus capitis de un nuevo pediculicida elaborado con aceite de oliva saponificado / Randomised clinical trial to evaluate the efficacy and safety of a new pediculicide made with saponified olive oil in the eradication of Pediculus humanus capitis

Introducción. El objetivo del estudio fue evaluar la eficacia y seguridad de un nuevo pediculicida en la erradicación del Pediculus humanus capitis. Material y métodos. Se diseñó un ensayo clínico aleatorizado en el que se seleccionaron niños con edades entre los 5 y los 15 años, en los que se diagnosticó pediculosis. El tratamiento se administró en los días 1 y 7 tras su selección, y fueron evaluados en 4 visitas (días 2, 7, 9 y 14). El producto en evaluación con aceite de oliva saponificado fue Inex Pediculicide Soap®, que fue comparado con Paranix®, con un mecanismo de acción similar. La variable principal de eficacia fue la erradicación del parásito en el día 14, realizándose el análisis por intención de tratar. Resultados. Participaron 6 pediatras pertenecientes a 5 centros de salud de la Comunidad de Madrid (España) y una clínica privada. Se seleccionaron 45 niños, de los que el 75,6% eran niñas (n=34). La media de edad fue de 7,1 años (IC 95% 6,3-7,9), perteneciendo el 80% de los niños a la clase social media. El 82,2% tenían antecedentes de pediculosis previas. La eficacia a los 14 días fue del 76,2% (IC 95% 52,8-91,8) en el grupo tratado con Inex Pediculicide Soap®, y del 79,2% (IC 95% 57,9-92,9) en el grupo de Paranix® (NNT=33,3). No se registraron efectos adversos al tratamiento. Conclusiones. Los 2 productos en evaluación se mostraron eficaces y seguros en el tratamiento de erradicación del Pediculus humanus capitis, sin diferencias estadísticamente significativas entre ellos (AU)

Introduction. The aim of the study was to evaluate the efficacy and safety of a new pediculicide in the eradication of Pediculus humanus capitis infestation. Material and methods. A randomised clinical trial was designed, in which children aged between 5 and 15 years diagnosed with pediculosis were selected. Treatment was administered on days 1 and 7 after selection, and they were evaluated in 4 visits (day 2, 7, 9, and 14). The product under evaluation with saponified olive oil was Inex Pediculicide Soap®, which was compared with Paranix®, with a similar mechanism of action. The primary efficacy endpoint was the eradication of the parasite by day 14 (louse-free rate), using an intention to treat analysis. Results. Six paediatricians from 5 Primary Health Care centres in the Community of Madrid (Spain) and one private clinic participated in the study. A total of 45 children were included, of which 75.6% were girls (n=34). The mean age was 7.1 years (95% CI 6.3-7.9). The large majority (80%) were middle class, and 82.2% had a history of previous pediculosis. The efficacy at 14 days was 76.2% (95% CI 52.8-91.8) in the group treated with Inex Pediculicide Soap® group, and 79.2% (95% CI 57.9-92.9) in Paranix® group (NNT=33.3). No adverse effects were observed with treatment. Conclusions. The 2 products were effective and safe in the eradication therapy Pediculus humanus capitis, with no statistical differences (AU)