Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
Actinic Keratosis, Organ or Tissue Transplant; Complications
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Photodynamic Therapy
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or dorsal hands. - Patients in the solid organ transplant arm of the study must have had either a kidney or liver transplant, and the transplantation surgery must have occurred at least 2 years prior to enrollment.
Exclusion Criteria:
- Pregnant or nursing
- Currently participating in another clinical trial
- Using any topical treatment for their actinic keratoses
- Currently being treated for other cancers with medical or radiation therapy
- Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any component of the study material
- Patients with a history of a photosensitivity disease, including porphyria cutanea tarda
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Solid Organ Transplant with AKs
Actinic Keratoses
Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.
Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.