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NCT00571974 · ClinicalTrials.gov registry record · Phase 1
Treatment of Oral Premalignant Lesions With 5-ALA PDT
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00571974: Completed Phase 1 study, sponsored by University of Arkansas.
NCT00571974 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00571974, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area. The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.
Primary Outcome
The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.
Interventions
- DEVICE PDL-585, ScleroPLUS laser
- DRUG 5-Aminolevulinic Acid (Levulan KerastickTM)
- PROCEDURE Fluorescence Diagnosis Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT00571974 record still lists
NCT00571974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which PDL-585, ScleroPLUS laser is the first listed.
NCT00571974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00571974 about?
NCT00571974 is a clinical study titled "Treatment of Oral Premalignant Lesions With 5-ALA PDT". Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area. The investigators hypothesized th...
What is the current status of trial NCT00571974?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00571974?
The interventions under investigation include: PDL-585, ScleroPLUS laser (DEVICE), 5-Aminolevulinic Acid (Levulan KerastickTM) (DRUG), Fluorescence Diagnosis Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT00571974?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00571974's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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