Condition: Actinic Keratosis · Sponsor: Sun Pharmaceutical Industries, Inc.
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.
This description comes directly from the study's public registry record.
Head, Regulatory Affairs · 0226645 · Clinical.Trial@sunpharma.com
Always discuss trial participation with your own doctor first.
| Medical Dermatology Specialist | Phoenix, Arizona, United States | Recruiting |
| Center for Dermatology Clinical Research, Inc | Fremont, California, United States | Recruiting |
| Clarity Dermatology, PLLC | Castle Rock, Colorado, United States | Recruiting |
| Center for Clinical and Cosmetic Research | Aventura, Florida, United States | Recruiting |
| Ziaderm Research LLC | North Miami Beach, Florida, United States | Recruiting |
| Northwest Clinical Trials, Inc. | Boise, Idaho, United States | Recruiting |
| Arlington Dermatology | Rolling Meadows, Illinois, United States | Recruiting |
| The Indiana Clinical Trials Center, PC | Plainfield, Indiana, United States | Recruiting |
| Minnesota Clinical Study Center | New Brighton, Minnesota, United States | Recruiting |
| Medisearch, LLC | Saint Joseph, Missouri, United States | Recruiting |
| Oregon Dermatology and Research Center | Portland, Oregon, United States | Recruiting |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting, Pennsylvania, United States | Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07144852