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

Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Actinic Keratosis; Organ or Tissue Transplant; Complications

Intervention: 5-Fluorouracil (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: The Cleveland Clinic


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.

Clinical Details

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

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

Primary outcome: Accumulation of PpIX

Secondary outcome:

AK clearance

Development of new AKs


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Cleveland Clinic, Cleveland, Ohio 44195, United States
Additional Information

Starting date: September 2011
Last updated: August 2, 2015

Page last updated: August 23, 2015

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