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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis, Organ or Tissue Transplant; Complications

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Accumulation of PpIX

Outcome Description:

The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region). (Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen).

Outcome Time Frame:

Day 7 of the study

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

09-1050

NCT ID:

NCT01525329

Start Date:

September 2011

Completion Date:

December 2014

Related Keywords:

  • Actinic Keratosis
  • Organ or Tissue Transplant; Complications
  • Actinic Keratosis
  • Photodynamic Therapy
  • Keratosis
  • Keratosis, Actinic
  • Precancerous Conditions
  • Skin Diseases

Name

Location
Cleveland Clinic Cleveland, Ohio  44195