Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2016-11
- Completion
- 2016-12
Outcome
Met primary endpoint
Stopped: “study drug no longer available in the United States”
registry analysis (unspecified test); Transplant With AKs; 5FU + PDT vs Transplant With AKs; PDT Only; p < 0.007; t-test, 2 sided NCT01525329 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | fluorouracil | Small molecule | — | Topical |