Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis

Inclusion Criteria: * Must be able to understand and voluntarily sign an informed consent form * Must be male or female ≥ 18 years of age at the time of consent * Must be able to adhere to the study visit schedule and other protocol requirements * Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation Exclusion Criteria: * Inability to provide voluntarily consent or mentally incompetent * Active herpes labialis lesions * Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study * Subjects with any other skin condition that might affect the evaluation of the study disease * Pregnant or breastfeeding female subjects * Subjects who have used any investigational medication within one month prior to study entry * Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis * Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry * Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry * Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity * Subjects who are frequently exposed to u…