ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Actinic KeratosesSkin Neoplasms
Interventions
DRUG

Aminolevulinic Acid

20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

OTHER

Vehicle

Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

Trial Locations (7)

10029

The Mount Sinai Medical Center, New York

19111

Fox Chase Cancer Center, Philadelphia

33136

University of Miami, Miami

37204

Vanderbilt University Medical Center, Nashville

92697

University of California, Irvine, Irvine

94115

University of California, San Francisco, San Francisco

02111

Tufts Medical Center, Boston

Sponsors
All Listed Sponsors
lead

DUSA Pharmaceuticals, Inc.

INDUSTRY