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Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Sponsor: Sun Pharmaceutical Industries, Inc.
Summary
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.
Official title: Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Upper Extremities
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2025-11-29
Completion Date
2027-04
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Solution for topical use
Vehicle
Solution for topical use
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
BLU-U® blue light PDT illuminator
Locations (20)
Medical Dermatology Specialist
Phoenix, Arizona, United States
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Clarity Dermatology, PLLC
Castle Rock, Colorado, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Ziaderm Research LLC
North Miami Beach, Florida, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Medisearch, LLC
Saint Joseph, Missouri, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
J&S Studies, Inc
College Station, Texas, United States
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, United States
Dermatology of Seattle & Bellevue
Burien, Washington, United States
Premier Clinical Research
Spokane, Washington, United States