Study of Reformulated Levulan Kerastick with Photodynamic Therapy for Treating Actinic Keratosis on One Upper Arm in Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of a reformulated Levulan Kerastick solution containing aminolevulinic acid hydrochloride ALA HCl 20%, combined with photodynamic therapy PDT, for treating actinic keratosis AK lesions on the upper extremities. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study focuses on adults with 4-8 mild to moderate AK lesions on one arm. The study aims to assess complete clearance of AK lesions and other related outcomes including partial clearance, lesion count changes, recurrence, cosmetic response, and patient satisfaction. Participants will be randomly assigned to receive either the active treatment with reformulated Levulan Kerastick plus blue light PDT or a vehicle solution plus blue light PDT. Treatment involves applying the solution with occlusion and incubation followed by exposure to blue light using the BLU-U4170E device. Up to two PDT sessions may be administered depending on lesion clearance. The study includes a control group receiving the vehicle solution to compare outcomes. During the study, participants will undergo evaluations at multiple time points including weeks 4, 8, 12, 20, and 24 to assess lesion clearance, cosmetic response, and patient satisfaction. Safety monitoring includes checks for adverse events, local skin reactions, vital signs, and laboratory tests. The primary outcome, complete clearance rate, will be measured at week 12. The total study duration involves follow-up through week 24 to assess sustained effects and recurrence rates.

Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities