Status:
TERMINATED
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Actinic Keratosis
Organ or Tissue Transplant; Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 g...
Detailed Description
This clinical trial will test a new combination of 5-fluorouracil cream (5FU) and methylaminolevulinate photodynamic therapy (MAL-PDT), versus MAL-PDT alone, as treatment for actinic keratoses (AKs) i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01525329
Start Date
September 1 2011
End Date
December 1 2016
Last Update
March 15 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195