Pharmacokinetic Study of Reformulated Levulan Kerastick and Photodynamic Therapy for Actinic Keratosis on Face or Upper Arms

What this Trial Is About

Researchers are studying how the body absorbs and responds to a reformulated Levulan Kerastick drug applied to actinic keratosis AK lesions on the forearms or face, followed by photodynamic therapy PDT using blue light. This phase 1 pharmacokinetic study aims to measure blood levels of the active ingredient aminolaevulinic acid and its by-product protoporphyrin IX to understand drug behavior during treatment. Participants will be assigned to one of two groups based on lesion location cohort A with treatment on both forearms covered during a 3-hour incubation, or cohort B with treatment on the face without covering during incubation. After incubation, an 8-minute and 20-second light therapy is applied. Serial blood samples are collected at multiple timepoints up to 48 hours after dosing to measure drug levels. During the study, participants will have blood drawn frequently on day 1 through day 3 to monitor pharmacokinetics. Researchers will assess plasma drug concentrations and evaluate safety and tolerability through day 29. The total participation lasts from treatment initiation through follow-up assessments, ensuring close monitoring of drug absorption and participant health.

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