Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
Status:
Terminated
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This randomized, intra-patient comparative study is designed to investigate the combination
regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for
its ability to generate significantly elevated levels of the target photosensitizer,
protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat
and prevent recurrence of AKs. The target population comprises patients with solid organ
transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for
possible influences of immunosuppression.