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.
Single group
Investigational drug
DrugThe study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.
Photodynamic therapy
DeviceThe study drug will be applied to the treatment area containing an acceptable number of AK lesions. If enrolled in group A (Cohort A), the treatment area will be on both forearms. During an incubation period of 3 hours the treatment area on both forearms will be covered. After the dressing will be removed, and the light therapy will begin and last for 8 minutes and 20 seconds. If you are enrolled in group B (Cohort B), the treatment area will be on the face. During the incubation period of 3 hours the treatment area will not be covered. After, the light therapy will begin and last for 8 minutes and 20 seconds. After treatment, the study staff will perform serial blood draws for PK testing at pre-determined time points during the day.
Plasma concentrations
To evaluate the potential systemic exposure of ALA and protoporphyrin IX (PpIX) when reformulated Levulan Kerastick containing ALA HCl for topical solution, 20% is applied topically in a maximal use setting in separate cohorts of patients with actinic keratoses (AKs) involving the upper extremities or the face.
Safety/Tolerability
To evaluate safety/tolerability (local and systemic) of reformulated Levulan Kerastick in these cohorts.
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