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From the Food and Drug Administration
February 2, 2000

First Drug Device to Treat Actinic Keratoses

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JAMA. 2000;283(5):596. doi:10.1001/jama.283.5.596-JFD00000-2-1

The FDA has approved aminolevulinic acid HCl (ALA HCl) (Levulan Kerastick for topical solution, 20%, DUSA Pharmaceuticals Inc, Valhalla, NY) to be used with photodynamic therapy for the treatment of actinic keratoses (AKs) of the face or scalp. It is the first combined drug and device designed for targeted treatment that can be limited to the lesion site(s).

Levulan Kerastick consists of a plastic tube with an applicator and two sealed glass ampules, one containing an alcohol-based solution vehicle and the other containing 354 mg of ALA HCl as a dry solid. The topical solution is prepared just prior to its use by breaking the ampules and shaking the applicator to mix the contents. The solution is applied by a physician directly to the AK lesions, and 14 to 18 hours later is photoactivated with the Blu-U Blue Light photodynamic therapy illuminator, a special radiation source designed to provide a uniform distribution of blue light to the affected face or scalp areas. Levulan Kerastick is intended for use only with the Blu-U Blue Light.

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