WebMD Medical News
Daniel J. DeNoon
Laura J. Martin, MD
Feb. 7, 2012 -- The FDA today approved Sklice, a no-comb, 10-minute treatment for head lice.
The announcement comes from Sanofi Pasteur U.S., which last year acquired the developer of the treatment, Topaz Pharmaceuticals.
Sklice is a prescription topical (on-the-skin) lotion containing a 0.5% solution of ivermectin, a powerful parasite killer. It can be used in kids as young as 6 months.
In clinical trials, a single home treatment got rid of head lice in about three-fourths of kids. Fewer than 1% of kids had negative side effects, which included pinkeye, redness in the whites of the eye, eye irritation, dandruff, dry skin, and a burning sensation.
According to Sanofi consultant Bill Ryan, DVM, who conducted the clinical trials for Topaz, side effects were seen in only 0.1% of kids.
"It speaks to the safety of this product that there is no need for covering the eyes or using gloves," Ryan tells WebMD. "Ivermectin has been used in pill form in a billion people over 20 years. I think that should put people's minds at ease."
With many current head lice medications, parents are encouraged to comb out nits after treatment. That is not necessary with Sklice, although parents may use a nit comb if they prefer.
Sklice is formulated with shea butter and olive oil, Ryan says, to make it especially "user friendly."
Sanofi says Sklice should be available in a few months. The company has not yet announced a price.
SOURCES:Bill Ryan, DVM, Ryan Mitchell Consultants.News release, Sanofi Pasteur U.S.Sklice label.
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