Sklice，主要成分为伊维菌素（ivermectin，IVM），由法国赛诺菲-巴斯德（Sanofi Pasteur）公司研制，1996年首次被美国食品药品监督局（FDA）批准口服片剂用于头虱的治疗，2012年2月FDA批准了0.5%的Sklice洗剂用于6个月以上患者的头虱治疗。
Manufacturer:
Sanofi Pasteur, Inc.
Pharmacological Class:
Pediculicide.
Active Ingredient(s):
Ivermectin 0.5%; lotion.
Indication(s):
Topical treatment of head lice infestations in patients ≥6 months old.
Pharmacology:
Ivermectin, a member of the avermectin class, causes death of parasites, primarily through binding selectively and with high affinity to glutamate-gated chloride channels, which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The selective activity of compounds of this class is attributable to the fact that some mammals do not have glutamate-gated chloride channels, the avermectins have a low affinity for mammalian ligand-gated chloride channels, and ivermectin does not readily cross the blood-brain barrier in humans.
Clinical Trials:
Two identical multicenter, randomized, double-blind, vehicle-controlled studies were conducted in subjects 6 months of age and older with head lice infestation. All subjects received a single application of either Sklice lotion or vehicle control 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, and were evaluated for all safety parameters.
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. Subjects with live lice present at any time up to the final evaluation were considered treatment failures. In Study 1, 76.1% of Sklice patients were free of live lice vs. 16.2% for vehicle. In Study 2, 71.4% of Sklice patients were lice free vs. 18.9% for vehicle.
Legal Classification:
Rx
Adults & Children:
<6 months: not established. ≥6 months: apply to dry hair in an amount sufficient (up to 1 tube) to thoroughly coat the hair and scalp. Leave on hair and scalp for 10 minutes, then rinse off with water.
Warnings/Precautions:
Not for oral, ophthalmic or intravaginal use. Avoid contact with eyes. Pregnancy (Category C). Nursing mothers.
Adverse Reaction(s):
Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, skin burning sensation.
How Supplied:
Single use tube—4oz
Last Updated:
7/23/2012
