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Combination Therapy With 5-FU and PDT for the Treatment of Post-transplant Premalignant Skin Disease


Combination Therapy With 5-Fluorouracil and Photodynamic Therapy for the Treatment of Post-transplant Premalignant Skin Disease




This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-FU and PDT, versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, 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.

Study Status: Active, not recruiting


Condition Intervention Phase
Actinic Keratosis
Organ or Tissue Transplant; Complications
Drug: 5-Fluorouracil Phase 3

Verified by The Cleveland Clinic December, 2013

Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic identifier: NCT01525329

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States


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