By Crina Frincu-Mallos, PhD
WASHINGTON, DC -- October 21, 2009 -- Spinosad is more efficacious than permethrin in treating pediculosis capitis in children, according to an analysis presented here at the 2009 American Academy of Pediatrics (AAP) National Conference & Exhibition.
"Spinosad, which did not require nit combing, was significantly more effective than permethrin in 2 studies reflecting actual use conditions, and most spinosad-treated participants required only 1 application," said Dow Stough, MD, Burke Pharmaceutical Research, Hot Springs, Arkansas, who presented the study results on October 19.
This retrospective analysis compared the data from 1,038 children aged 6 months and older with pediculosis capitis who were enrolled in 2 multicentre, randomised, blinded phase 3 studies.
The main goal was to compare the effectiveness of 1% spinosad crème rinse and 1% permethrin lice treatment under "actual use" conditions in patients with pediculosis capitis, explained Dr. Stough.
A total of 391 households were included in this analysis. For each household, "the youngest member having at least 3 live lice present was designated the primary participant," said Dr. Stough, adding that the other household members found to have lice received the same treatment as the primary member.
The product was applied once or twice, based on complete or partial eradication of lice after 1 dose.
Scalp evaluations for live lice were performed at baseline, day 7, and day 14 for one-time users, and at day 21 for participants who needed 2 applications.
The primary efficacy endpoint was the proportion of primary participants who accomplished complete eradication of lice 2 weeks after their last treatment.
In both studies, the majority of children treated with spinosad had succeeded in completely eradicating the head lice, 84.6% in study 1 and 86.7% in study 2. The use of permethrin was significantly less successful, with only 44.9% and 42.9% of children accomplishing total eradication (both studies, P < .001).
Furthermore, most participants in the spinosad groups required only 1 application (63.8% of patients in the first study and 86.2% in the second study). In contrast, most participants in the permethrin groups (64.4% and 60.3%) required 2 applications for complete eradication of head lice.
"Few adverse events were reported, but those occurring were mild/moderate in severity and included eye irritation, and ocular hyperaemia and application site erythema/irritation [both medications]," said Dr. Stough.
"These results confirm that spinosad is a more convenient and effective treatment for pediculosis capitis," concluded Dr. Stough.
[Presentation title: Comparative Efficacy and Safety of Spinosad and Permethrin Crème Rinses for Pediculosis Capitis (Head Lice). Abstract 5929]
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