[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].

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.