The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a treatment that uses application of blue light.
Provided written Informed Consent.
Patient is willing and able to comply with study protocol, visit schedule, and other study-related instructions/procedures, including in-clinic stay as required.
Patient is a male or non-pregnant female 18 to 85 years of age (inclusive) at Screening.
Patient has either 4 or more AK lesions on the upper extremities; or 6 or more AK lesions on the face. Lesions must be within an area of 25 cm2.
Patient is pregnant, lactating, or is planning to become pregnant during the study.
Patient has severe AK lesions within the Treatment Area.
Patient has untreated skin cancers or lesions suspicious for skin cancer within the Treatment Area.
Patient has an active herpes simplex infection OR a history of ≥2 outbreaks within past 12 months in the Treatment Area.