NCT07144852

Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%	Solution for topical use
OTHER	Vehicle	Solution for topical use
DEVICE	Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.	BLU-U® blue light PDT illuminator

Timeline

• Start date: 2025-11-29
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-08-28
• Last updated: 2026-02-20

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study