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ACTIVE NOT RECRUITING
NCT07144345
PHASE3

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

Sponsor: Sun Pharmaceutical Industries, Inc.

View on ClinicalTrials.gov

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

Interventions

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

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