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Recovery Begins When Treatment Ends
Erythema and edema resolved to baseline or improved by baseline by 4 weeks after therapy6
- The most common changes in lesion appearance after Levulan® PDT treatment were erythema and edema
Representative Patient Response
No scarring reported in clinical trials6
In 99% of active treatment patients, some or all lesions were erythematous shortly after treatment, while in 79% of vehicle-treated patients, some or all lesions were erythematous. In 35% of active treatment patients, some or all lesions were edematous, while no vehicle-treated patients had edematous lesions.
Important Risk 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.
Application of Levulan® Kerastick® should involve either scalp or face lesions, but not both simultaneously. Levulan® Kerastick® should not be applied to the periorbital area or allowed to contact ocular or mucosal surfaces.
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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