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Sanofi Announces FDA Approval Of Sklice® Lotion For The Treatment Of Head Lice

Widespread oral use of ivermectin began in 1987 to control river blindness (onchocerciasis) in humans. More than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by river blindness and other parasitic conditions.

Sklice Lotion was developed by Topaz Pharmaceuticals, which was acquired by Sanofi Pasteur in October, 2011.

Sklice Lotion Pivotal Trials

The FDA submission for Sklice Lotion included two identical multi-center, randomized, double-blind, vehicle-controlled studies conducted in subjects 6 months of age and older with head lice infestation. 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. Subjects were also evaluated for safety and local tolerability.  

The primary efficacy was assessed as the proportion of index subjects who were free of live lice at day 2 and through day 8 to the final evaluation 14 (+2) days following a single application. The secondary efficacy endpoint was the same assessment applied to the other enrolled subjects. Those with live lice present at any time up to the final evaluation were considered treatment failures.

Important Safety Information

No adverse events occurred at a rate greater than or equal to 1% in placebo-controlled trials using a single 10-minute treatment of Sklice Lotion in 379 patients ages 6 months and older. The most common adverse reactions (incidence <1%) were conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin and skin burning sensation.

The safety of Sklice Lotion has not been established in pediatric patients below the age of 6 months.  Sklice Lotion is not recommended in pediatric patients under 6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity due to a high ratio of skin surface area to body mass and the potential for an immature skin barrier and risk of ivermectin toxicity.

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