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.
Patient is a male or non-pregnant female aged 18-85 years.
Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart.
Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation.
Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
Parallel
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
DrugSolution for topical use
Vehicle
Other interventionSolution for topical use
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.
DeviceBLU-U® blue light PDT illuminator
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"
Actinic Keratosis Clearance rate (AKCR)
AKCR for each patient is calculated as 100 x \[1- (number of target AK lesions present at that particular visit/ number of target AK lesions present at Baseline)\]. Target lesions are those AK lesions that were identified at baseline and treated at baseline
Proportion of patients achieving clearance of target lesions in the Treatment Area
Target lesions are those AK lesions that were identified at baseline and treated at baseline.
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area
Partial Clearance Rate (PCR); i.e., Proportion of patients achieving partial clearance of AK lesions)
Partial clearance is defined as clearance of at least 75% of all AK lesions in the Treatment Area; lesions should no longer be palpable nor visible to be declared as "cleared".
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