NeLM news service
Horizon scanning: FDA approves Sklice™ (ivermectin) Lotion for the treatment of head lice

Source: PharmaLive

Date published: 08/02/2012 16:54

Summary
by: Sheetal Ladva

According to a Pharmalive report,  the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. The treatment involves a single 10-minute application without nit combing.

 

The approval was based on results of two randomized, double-blind phase III clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients from the United States who were 6 months of age and older. More subjects in the treatment group were louse-free without any nit combing after two weeks and less than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperaemia, eye irritation, dandruff, dry skin and skin-burning sensation. [No further absolute data available within PharmaLive report.]

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