Who is sponsoring NCT01525329?

NCT01525329 is sponsored by The Cleveland Clinic.

What condition does NCT01525329 study?

NCT01525329 studies Actinic Keratosis, Organ or Tissue Transplant; Complications.

What is the status of NCT01525329?

NCT01525329 is currently TERMINATED.

Last reviewed 2022-03-05 · How we verify

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

NCT01525329 Phase 3 TERMINATED Results posted

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 generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (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.

Details

Lead sponsor	The Cleveland Clinic
Phase	Phase 3
Status	TERMINATED
Enrolment	18
Start date	2011-09
Completion	2016-12

Conditions

Actinic Keratosis
Organ or Tissue Transplant; Complications

Interventions

5-Fluorouracil

Primary outcomes

Accumulation of Porphyrin (PpIX) — Day 7 of the study
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).

Countries

United States