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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: Clinical Trial Phase 3 study, sponsored by The Cleveland Clinic.
NCT01525329 is a Phase 3 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
Interventions
- DRUG 5-Fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
Why NCT01525329 stopped before completion
NCT01525329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Fluorouracil is the first listed.
NCT01525329 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525329's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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