A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel
group study of photodynamic therapy in organ transplant recipient subjects for treatment of
AK and the reduction of new NMSC.
Subjects will be randomized to one of the following two treatment groups (1:1) to receive
topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug)
or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire scalp OR both forearms 90 +/- 30 minutes
prior to BLUE light treatment for 16 minutes 40 seconds
- Group 2 will have VEH applied to the entire scalp OR both forearms 90 +/- 30 minutes
prior to BLUE light treatment for 16 minutes 40 seconds
Treatment Area (scalp or both forearms) must have had at least 2 NMSC in the past 12 months,
and must include a continuous 25 cm2 Target Area containing a minimum of 3 AKs, to be
eligible for treatment
Each subject may receive up to nine treatments. The initial four (4) ALA-PDT/VEH-PDT
treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given
every 6 +/-1 weeks. Post-treatment follow-up visit will be scheduled to occur 4 weeks after
the subject's final PDT.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Number of Skin Cancers within the Treatment Area
entire study
No
Stuart L Marcus, MD, PhD
Study Director
Sponsor GmbH
United States: Food and Drug Administration
DUSA-CP0104
NCT00865878
May 2009
September 2011
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
University of California, San Francisco | San Francisco, California 94143 |
Tufts Medical Center | Boston, Massachusetts 02111 |
University of Miami | Miami, Florida 33136 |
University of California, Irvine | Orange, California 92868 |
The Mount Sinai Medical Center | New York, New York 10029 |