An Open-Label, Two-Cohort, Pharmacokinetic Study in a Maximal Use Setting for Patients With Actinic Keratosis on the Upper Extremities or the Face
brief summary
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.
detailed description
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.
official title
An Open-Label, Single-Period, Pharmacokinetic Study of Aminolevulinic Acid (ALA) and Protoporphyrin IX (PpIX) When Reformulated Levulan Kerastick is Applied Topically in A Maximal Use Setting in Separate Cohorts of Patients With Actinic Keratosis on the Upper Extremities or Actinic Keratosis on the Face