NCT07144345

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (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 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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%	Solution for topical use
OTHER	Vehicle containing excipients only (VEH) without active ingredient	Solution for topical use
DEVICE	Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E	BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Timeline

• Start date: 2025-11-19
• Primary completion: 2027-01-01
• Completion: 2027-04-01
• First posted: 2025-08-27
• Last updated: 2026-03-05

Locations

10 sites across 1 country: United States

Regulatory

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