Treatment of Oral Premalignant Lesions With 5-ALA PDT

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
LeukoplakiaErythroplakia
Interventions
DEVICE

PDL-585, ScleroPLUS laser

PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue

DRUG

5-Aminolevulinic Acid (Levulan KerastickTM)

Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze

PROCEDURE

Fluorescence Diagnosis Imaging

FD Image taken prior to PDL-585 usage

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
lead

University of Arkansas

OTHER

NCT00571974 - Treatment of Oral Premalignant Lesions With 5-ALA PDT | Biotech Hunter | Biotech Hunter