High Ratings for Cosmetic Response
At 8 weeks most patients evaluated cosmetic response as good to excellent6
94% of patients treated with Levulan PDT evaluated their cosmetic response as good to excellent vs only 31% of vehicle-treated patients
Percent of patients rating cosmetic response as good to excellent
Physicians rated cosmetic response of most lesions as good to excellent6
92% of the AK lesions treated with Levulan PDT were graded as good to excellent cosmetic response by clinical investigators vs 35% for the vehicle-treated lesions
Percent of lesions graded as good to excellent cosmetic response
Important Safety Information
Levulan® Kerastick® plus blue light illumination using the BLU-U® blue light photodynamic therapy illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2) of the face or scalp.
Contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria, or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the Levulan Kerastick for Topical Solution.
Levulan® Kerastick® has not been tested on patients with inherited or acquired coagulation defects. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with the Levulan® Kerastick®.
Patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light prior to blue light treatment. Exposure may result in a stinging and/or burning sensation and may cause erythema or edema of the lesions. Patients should protect treated lesions from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light.
Transient local symptoms of stinging and/or burning, itching, erythema, and edema were observed in all clinical studies. Severe stinging and/or burning at one or more lesions being treated was reported by at least 50% of patients at some time during treatment. However, less than 3% of patients discontinued light treatment due to stinging and/or burning.
During light treatment, both patients and medical personnel should be provided with blue blocking protective eyewear, as specified in the BLU-U operating instructions to minimize ocular exposure.
WEB 1426 Rev B