Treatment of Oral Premalignant Lesions With 5-ALA PDT

NCT00571974 ↗

Phase 1/2 Completed 29 enrolled University of Arkansas

Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2012-01
Completion: 2012-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Phase II; p = 0.0001; One-sided exact binomial test NCT00571974 ↗

paper This response rate was far higher than the null-hypothesis 20% rate (P < 10(-10)) PMID 22106236 ↗

Publications

Results Shafirstein G, Friedman A, Siegel E, Moreno M, Baumler W, Fan CY, Morehead K, Vural E, Stack BC Jr, Suen JY. Using 5-aminolevulinic acid and pulsed dye laser for photodynamic treatment of oral leukoplakia. Arch Otolaryngol Head Neck Surg. 2011 Nov;137(11):1117-23. doi: 10.1001/archoto.2011.178.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aminolevulinic Acid	Diagnostic / imaging agent	345 mg	Topical