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 face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. 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 · 9122 66455645 · Clinical.Trial@sunpharma.com
Always discuss trial participation with your own doctor first.
| Center for Dermatology Clinical Research, Inc | Fremont, California, United States | Recruiting |
| Center for Clinical and Cosmetic Research | Aventura, Florida, 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 |
| Palmetto Clinical Trial Services, LLC | Greenville, South Carolina, United States | Recruiting |
| Tennessee Clinical Research Center | Nashville, Tennessee, United States | Recruiting |
| Premier Clinical Research | Spokane, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07144345