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ACTIVE NOT RECRUITING Phase 3

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

NCT07144345 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
  • OTHER Vehicle containing excipients only (VEH) without active ingredient
  • DEVICE Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

Study Locations (10)

California

  • Center for Dermatology Clinical Research, Inc — Fremont

Florida

  • Center for Clinical and Cosmetic Research — Aventura

Illinois

  • Arlington Dermatology — Rolling Meadows

Indiana

  • The Indiana Clinical Trials Center, PC — Plainfield

Minnesota

  • Minnesota Clinical Study Center — New Brighton

Missouri

  • Medisearch, LLC — Saint Joseph

Oregon

  • Oregon Dermatology and Research Center — Portland

South Carolina

  • Palmetto Clinical Trial Services, LLC — Greenville

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2025-11-19
Est. Completion 2027-04
Phase Phase 3

Sponsor

Sun Pharmaceutical Industries

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07144345

The ClinicalTrials.gov registry entry for NCT07144345 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries, which has 20 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 3 interventions — of which Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07144345 reports 10 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07144345 about?

NCT07144345 is a clinical study titled "Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp". 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 scal...

What is the current status of trial NCT07144345?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2025-11-19. Estimated completion is 2027-04.

What conditions does trial NCT07144345 study?

This clinical trial studies the following conditions: Actinic Keratosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07144345?

The interventions under investigation include: Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% (DRUG), Vehicle containing excipients only (VEH) without active ingredient (OTHER), Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07144345?

This trial is sponsored by Sun Pharmaceutical Industries, which has 20 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07144345 being conducted?

This trial has 10 study locations across California, Florida, Illinois, Indiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial