Sanofi announced that the FDA has approved Sklice (ivermectin lotion) 0.5% for the topical treatment of head lice in patients ≥6 months of age. This approval was based on data from two Phase 3, randomized, double-blind clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients who were ≥6 months of age.
Sklice Lotion or placebo was dispensed to all subjects for application to dry hair and scalp followed by a rinsing after 10 minutes, with instructions not to use a nit comb. For the evaluation of efficacy, the youngest subject from each household was considered to be the index subject of the household (n=289). Other enrolled infested household members received the same treatment as the youngest subject. Significantly more subjects in the Sklice Lotion group were louse-free, Sklice was well-tolerated, and the majority of Sklice-treated patients were lice-free without any nit combing after two weeks.
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