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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 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 29 participants.

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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.

Interventions

  • DEVICE PDL-585, ScleroPLUS laser
  • DRUG 5-Aminolevulinic Acid (Levulan KerastickTM)
  • PROCEDURE Fluorescence Diagnosis Imaging

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2007-01
Est. Completion 2012-01
Phase Phase 1

Sponsor

University of Arkansas

318 total trials

What the Registry Record Tells You About NCT00571974

The ClinicalTrials.gov registry entry for NCT00571974 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which PDL-585, ScleroPLUS laser is the first listed.

NCT00571974 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.