An Open-Label, Two-Cohort, Pharmacokinetic Study in a Maximal Use Setting for Patients With Actinic Keratosis on the Upper Extremities or the Face

This is a pharmacokinetic (PK) study which involves measuring drug levels in blood. Blood levels of Levulan Kerastick's active ingredient (aminolaevulinic acid, ALA) and its by-product (protoporphyrin IX, PpIX) will be measured. PK blood samples will be collected at: pre-application, 15 minutes, 0.5 hours, 1 hour, 2 hours, 3 hours, 3.5 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, and 16 hours after dose on Day 1; at 24 hours and 36 hours post-dose on Day 2; and at 48 hours post-dose on Day 3.

Inclusion criteria

• 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 in good general health and free of any disease state or physical condition.
• Patient has veins suitable for repeat blood draws.
• Patient is willing to abstain from sunbathing, solarium use, exposure to artificial tanning devices.
• Patient is willing to follow a consistent skin care routine without significant change.
• Patient is willing to stop using all topical products within the Treatment Area(s) starting from 8 hours prior to initiation of treatment.
• Patients who are women of childbearing potential must agree to use a highly effective method of contraception during the study.
• Patients who are male with female partners of childbearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before initiation of treatment at Baseline.

Exclusion criteria

• 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.
• Patient has significant skin abnormality involving the Treatment Area
• Patient has a history of skin sensitivity to light.
• Patient has known hypersensitivity to one or more components of the IP.
• Patient has a history of lead poisoning or a history of significant exposure to lead.
• Patient smokes more than 10 cigarettes/day.
• Patient has a suppressed immune system.
• Patient has a coagulation defects.
• Patient has a Body Mass Index (BMI) > 32.0 kg/m2.
• Patient has donate blood recently.
• Patient is positive for HIV, Hepatitis B and/or Hepatitis C.
• Patient has history of alcohol or drug abuse during the past year prior.
• Patient has a positive urine screen for drugs of abuse.
• Patient has abnormal labs at Screening.
• Patient had a major surgery within 30 days or plans to have surgery during the study.
• Patient has any condition which would make it unsafe for the patient to participate in this research study or interferes with assessment/interpretation of study outcomes.
• Patient received any topical or systemic therapies on the Treatment Area within a certain amount of time.
• Patient is currently enrolled in an investigational drug, investigational biologic, or investigational device study.
• Patient has received an investigational drug, investigational biologic, or investigational device treatment within 30 days or 5 half-lives of the experimental agent, whichever is longer, prior to initiation of treatment at Baseline.