Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Start Date
11/29/2025
Completion Date
4/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Vehicle
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
Conditions
Locations
Medical Dermatology Specialist
Phoenix, Arizona 85006
United States
Center for Dermatology Clinical Research, Inc
Fremont, California 94538
United States
Clarity Dermatology, PLLC
Castle Rock, Colorado 80109
United States
Center for Clinical and Cosmetic Research
Aventura, Florida 33180
United States
Ziaderm Research LLC
North Miami Beach, Florida 33162
United States
Northwest Clinical Trials, Inc.
Boise, Idaho 83704
United States
Arlington Dermatology
Rolling Meadows, Illinois 60008
United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
United States
Minnesota Clinical Study Center
New Brighton, Minnesota 55112
United States
Medisearch, LLC
Saint Joseph, Missouri 64506
United States
Oregon Dermatology and Research Center
Portland, Oregon 97210
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania 19462
United States
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina 29621
United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina 29615
United States
Dermatology Associates of Knoxville
Knoxville, Tennessee 37909
United States
Tennessee Clinical Research Center
Nashville, Tennessee 37215
United States
J&S Studies, Inc
College Station, Texas 77845
United States
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas 78660
United States
Dermatology of Seattle & Bellevue
Burien, Washington 98168
United States
Premier Clinical Research
Spokane, Washington 99202
United States