Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp

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.

NCT Number	NCT07144345
Lead Sponsor	Sun Pharmaceutical Industries, Inc.
Conditions	Actinic Keratosis
Enrollment	160 participants
Start Date	2025-11-19
Primary Completion	2027-01 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-22