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 Face and (Bald) Scalp
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.
Arms & interventions
- DrugReformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Solution for topical use
- OtherVehicle containing excipients only (VEH) without active ingredient
Solution for topical use
- DeviceBlue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
BLU-U® blue light Photodynamic Therapy (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 12
Proportion of patients achieving clearance of target lesions in the Treatment Area
Time frame: Weeks 4, 8, 12, 20, and 24.
Actinic Keratosis Clearance rate (AKCR)
Time frame: Weeks 4, 8, 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 to Weeks 4, 8, 12, 20, and 24.
Time frame: Weeks 4, 8, 12, 20, and 24
Percent change in total AK lesion area from Baseline to Weeks 8, 12, and 24.
Time frame: Weeks 8, 12, and 24
Investigator Assessment of Cosmetic Response at Weeks 12, 20, and 24.
Time frame: Weeks 12, 20, and 24
Patient Assessment of Cosmetic Response at Weeks 12, 20, and 24.
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
Time frame: Week 24
Eligibility criteria
Study locations (10)
Center for Dermatology Clinical Research, Inc
Fremont, California, 94538
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
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
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, 29615
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Premier Clinical Research
Spokane, Washington, 99202