Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Start Date
11/19/2025
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 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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Vehicle containing excipients only (VEH) without active ingredient
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
Conditions
Locations
Center for Dermatology Clinical Research, Inc
Fremont, California 94538
United States
Center for Clinical and Cosmetic Research
Aventura, Florida 33180
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
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina 29615
United States
Tennessee Clinical Research Center
Nashville, Tennessee 37215
United States
Premier Clinical Research
Spokane, Washington 99202
United States