Levulan photodynamic therapy is a treatment method for certain skin conditions developed by DUSA Pharmaceuticals. The active ingredient is δ-aminolevulinic acid (ALA).
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Actinic keratosis
U.S. Food and Drug Administration (FDA) approval for actinic keratosis was received in December 1999.
Treatment protocol
A 20% solution of ALA is applied to the lesions, and after a 1-4 hour wait (depending on body location) to allow proper penetration of the skin, the treatment area is irradiated with blue light for 15 minutes. This generates reactive oxygen species in the skin that can lead to cell death. The treated areas are sensitive to light, and patients must protect themselves against bright sunshine for up to 48 hours after treatment. Patients must stop using topical acne medicine and avoid steam rooms, hot showers, and generally protect the skin for up to one week after treatment.
Acne
Levulan is also prescribed for the treatment of acne but this is an off-label use, which means it is not approved by the FDA.
On October 2008 Dusa Pharmaceuticals announced that it was no longer developing Levulan for the treatment of acne after the phase II results failed to show statistically significant results.
Barrett's esophagus
A phase II trial was initiated in 2004. In May 2007 the U.S. FDA granted Orphan Drug Designation for Levulan PDT for the treatment of esophageal dysplasia, a complication of Barrett's esophagus.