High Clearance in the Majority of Patients
Complete response demonstrated in a high percentage of patients6,7*
At 8 weeks...
• 75% clearance of AK lesions was experienced by 77% of patients treated with Levulan PDT vs 18% of vehicle-treated patients (p<0.001)
• 83% of the patients treated with Levulan had 75% clearance of face lesions and 58% of the patients had 75% clearance of scalp lesions.
• 100% clearance of AK lesions was experienced by 66% of patients treated with Levulan PDT vs 11% of vehicle-treated patients (p<0.001)
• 70% of the patients treated with Levulan had 100% clearance of face lesions and 53% of the patients had 100% clearance of scalp lesions.
Percent of patients who had a 75-100% response at 8 weeks
* Results from two identically designed, Phase III studies. These were multi-center, blinded, active treatment-controlled, randomized, uneven parallel group, two-arm studies. A total of 243 patients were randomized at a 3 to 1 Levulan to vehicle ratio. Patients returned for follow-up visits 24 hours after BLU-U light treatment and at weeks 1, 4 and 8. Those patients who were not complete responders at week 8 had retreatment of the persistent target lesions at week 8. All patients returned at 12 weeks after the initial treatment.
High Clearance Maintained
In a Phase IV study of 110 patients...
High percentage of lesions remained cleared at 12 months8*
• 78% of lesions treated with Levulan PDT maintained complete response at 12 months
Percentage of lesions cleared
*Results from a multi-center, open-label, phase IV study of patients with AKs on the face or scalp. The study objectives were to characterize further the efficacy and safety of ALA-PDT by extending previous work. Sixty percent of the patients received a second ALA-PDT treatment, limited to the target AKs still present at month 2.
Pre-protocol analysis used observed values only. Patients whose visits fell outside predefined visit windows or had missing responses were excluded from a particular visit.
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.
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