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Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities

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 your arms. AKs are rough, scaly patches on the skin that can sometimes turn into skin cancer. About 260 adults with 4-8 mild to moderate AK lesions on one arm will participate. You would either receive the active treatment or a vehicle (a solution without the active drug) followed by blue light exposure. The study wants to see how many people 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 where neither you nor the evaluators will know if you're receiving the active treatment or a control. Approximately 260 adult patients will participate.
What's involved
Up to two photodynamic therapy (PDT) sessions may be given, depending on how your lesions clear. The primary goal is to measure complete clearance at Week 12.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring the success of the treatment is at Week 12.

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

NCT07144852

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

Recruiting
PHASE3Ages 18–85InterventionalTreatment
Sun Pharmaceutical Industries, Inc.
~260 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%VehicleBlue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.

At a glance

Recruiting sites
20 of 20 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

Conditions

Actinic Keratosis

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Actinic Keratosis

NCT07144852

Where you'd take part

This study runs at 20 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

  • Clarity Dermatology, PLLC

    Castle Rock, Coloradono site contact published

    Recruiting

  • Dermatology Associates of Knoxville

    Knoxville, Tennesseeno site contact published

    Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvaniano site contact published

    Recruiting

  • Dermatology of Seattle & Bellevue

    Burien, Washingtonno site contact published

    Recruiting

  • J&S Studies, Inc

    College Station, Texasno 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.

Who to contact

Head, Regulatory Affairs
[email protected]
0226645 · ext. 5789
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • 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"