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NCT01525329 · ClinicalTrials.gov registry record · Phase 3
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
A Phase 3 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT01525329 is a Phase 3 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 18 participants.
The verdict
NCT01525329, a Phase 3 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01525329
The ClinicalTrials.gov registry entry for NCT01525329 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 5-Fluorouracil is the first listed.
NCT01525329 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01525329 about?
NCT01525329 is a clinical study titled "Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease". 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 le...
What is the current status of trial NCT01525329?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2011-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01525329?
The interventions under investigation include: 5-Fluorouracil (DRUG).
Who is sponsoring clinical trial NCT01525329?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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