Sklice is a new topical formulation of ivermectin, an antiparasitic that has been used orally for more than 20 years to control onchocerciasis in humans. Ivermectin was developed from a soil bacterium that produces avermectins, a family of compounds shown to bind selectively and with high affinity to certain ion channels present in invertebrate nerve and muscle cells, but not in mammals. Widespread oral use of ivermectin began in 1987, and to date more than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by onchocerciasis and other parasitic conditions.

Sklice lotion, a product of Sanofi (Paris, Franc), was approved by the US Food and drug Administration (FDA) based on the results of two randomized, double-blind phase 3 clinical trials that compared Sklice with a placebo in 781 patients from the United States who were six months of age and older. Significantly more subjects in the Sklice 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. Less than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and skin-burning sensation.

“The approval of Sklice Lotion provides physicians and parents with a new treatment option for head lice, a condition that is notoriously frustrating to treat,” said Kenneth Guito, general manager of Sanofi-Topaz. “Through a unique mode of action, Sklice Lotion resolves most head lice infestations in one application, and is very well-tolerated.”

Head lice are wingless parasites that live close to the human scalp and feed on human blood. They move by crawling and are mainly spread by head-to-head contact, most commonly among preschool children attending childcare, elementary schoolchildren, and the household members of infested children. Infrequently, transmission may also occur by contact with items recently used by an infested person, such as clothing, brushes, towels, or pillows. Although head lice infestation is not related to cleanliness, patients experience social stigma, embarrassment, and low self-esteem. The process of eradicating lice and their nits can also be stressful, tedious, and costly.

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