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Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Sponsor: Sun Pharmaceutical Industries, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2025-11-19
Completion Date
2027-04
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
Solution for topical use
Vehicle containing excipients only (VEH) without active ingredient
Solution for topical use
Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E
BLU-U® blue light Photodynamic Therapy (PDT) illuminator
Locations (10)
Center for Dermatology Clinical Research, Inc
Fremont, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
Medisearch, LLC
Saint Joseph, Missouri, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Premier Clinical Research
Spokane, Washington, United States