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

This study is testing a reformulated version of Levulan Kerastick (aminolevulinic acid HCl 20%) combined with blue light Photodynamic Therapy (PDT) for treating actinic keratosis (AK) on the face or bald scalp. Researchers want to see how well this treatment works compared to a vehicle (a solution without the active ingredient). You may be eligible if you are an adult between 18 and 85 years old and have 4-8 mild to moderate AK lesions on your face or bald scalp. The main goal is to see how many patients achieve complete clearance of their AK lesions by Week 12. The current status of this study is unclear.

Study design
This is a Phase 3, randomized, multi-center study involving about 160 adult patients. It is evaluator-blind, meaning the people assessing your progress won't know which treatment you received, and it compares the active drug to a vehicle.
What's involved
You would be randomized into one of four treatment groups. You may receive up to two PDT sessions, depending on how your lesions clear.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at Week 12 to see if your lesions have completely cleared.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07144345

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

Recruiting
PHASE3Ages 18–85InterventionalTreatment
Sun Pharmaceutical Industries, Inc.
~160 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%Vehicle containing excipients only (VEH) without active ingredientBlue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.
Measured over Week 12
Actinic Keratosis

NCT07144345

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arlington Dermatology

    Rolling Meadows, Illinoisno site contact published

    Recruiting

  • Center for Clinical and Cosmetic Research

    Aventura, Floridano site contact published

    Recruiting

  • Center for Dermatology Clinical Research, Inc

    Fremont, Californiano site contact published

    Recruiting

  • Medisearch, LLC

    Saint Joseph, Missourino site contact published

    Recruiting

  • Minnesota Clinical Study Center

    New Brighton, Minnesotano site contact published

    Recruiting

  • Oregon Dermatology and Research Center

    Portland, Oregonno site contact published

    Recruiting

  • Palmetto Clinical Trial Services, LLC

    Greenville, South Carolinano site contact published

    Recruiting

  • Premier Clinical Research

    Spokane, Washingtonno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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  • Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.Week 12

    Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared".