Levulan Kerastick + PDT for Actinic Keratosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Reformulated Levulan Kerastick
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Levulan application + incubation time (with occlusion) + blue light application
Vehicle application + incubation time (with occlusion) + blue light application
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Who Is Running the Clinical Trial?
Sun Pharmaceutical Industries, Inc.
Lead Sponsor
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