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
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.
Arms & interventions
- DrugReformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Solution for topical use
- OtherVehicle
Solution for topical use
- DeviceBlue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
BLU-U® blue light PDT illuminator
Outcome measures
Primary
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area)
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared"
Time frame: Week 12
Secondary
Actinic Keratosis Clearance rate (AKCR)
Time frame: Week 4, 8 ,12, 20, and 24
Proportion of patients achieving clearance of target lesions in the Treatment Area
Time frame: Weeks 4, 8, 12, 20, and 24
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area
Time frame: Weeks 4, 8, 20, and 24
Partial Clearance Rate (PCR); i.e., Proportion of patients achieving partial clearance of AK lesions)
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion count from Baseline
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline
Time frame: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response
Time frame: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response
Time frame: Weeks 12, 20, and 24
Patient Satisfaction Score (PSS) at Weeks 12, 20, and 24.
Time frame: Weeks 12, 20, and 24
Recurrence Rate at Week 24. Measured as proportion of patients presenting with at least one recurrent lesion during the follow-up period, after having achieved complete clearance at Week 12.
Time frame: Week 24
Eligibility criteria
Study locations (20)
Medical Dermatology Specialist
Phoenix, Arizona, 85006
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Clarity Dermatology, PLLC
Castle Rock, Colorado, 80109
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Ziaderm Research LLC
North Miami Beach, Florida, 33162
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
Arlington Dermatology
Rolling Meadows, Illinois, 60008
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Medisearch, LLC
Saint Joseph, Missouri, 64506
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, 29621
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29615
Dermatology Associates of Knoxville
Knoxville, Tennessee, 37909
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
J&S Studies, Inc
College Station, Texas, 77845
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Dermatology of Seattle & Bellevue
Burien, Washington, 98168
Premier Clinical Research
Spokane, Washington, 99202