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NCT07144852 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Actinic Keratosis, sponsored by Sun Pharmaceutical Industries.

Active
Registry status
Phase 3
Development phase
260
Enrollment target
20
Study locations

NCT07144852: Active Phase 3 study of Actinic Keratosis, sponsored by Sun Pharmaceutical Industries.

NCT07144852 is a Phase 3 study of Actinic Keratosis that is active but no longer recruiting, run by Sun Pharmaceutical Industries. The registered enrollment target is 260 participants, above the 173-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07144852, a Phase 3 study of Actinic Keratosis, is active but no longer recruiting, sponsored by Sun Pharmaceutical Industries.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
260 participants
Enrollment target
20
Study locations

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 upper extremities. Approximately 260 adult patients with 4-8 mild to moderate AK lesions on one arm will be randomized to receive either active treatment or vehicle control, followed by exposure to blue light. 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.

Primary Outcome

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"

Conditions Studied

Actinic Keratosis

Interventions

  • OTHER Vehicle
  • DRUG Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%
  • DEVICE Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E.

Study Locations (20)

Florida

  • Center for Clinical and Cosmetic Research - Aventura
  • Ziaderm Research LLC - North Miami Beach

South Carolina

  • Palmetto Clinical Trial Services, LLC - Anderson
  • Palmetto Clinical Trial Services, LLC - Greenville

Tennessee

  • Dermatology Associates of Knoxville - Knoxville
  • Tennessee Clinical Research Center - Nashville

Texas

  • J&S Studies, Inc - College Station
  • Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research - Pflugerville

Washington

  • Dermatology of Seattle & Bellevue - Burien
  • Premier Clinical Research - Spokane

Arizona

  • Medical Dermatology Specialist - Phoenix

California

  • Center for Dermatology Clinical Research, Inc - Fremont

Colorado

  • Clarity Dermatology, PLLC - Castle Rock

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2025-11-29
Est. Completion 2027-04
Phase Phase 3
Sun Pharmaceutical Industries

48 total trials

What the registry record for NCT07144852 still lists

NCT07144852 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (50% higher).

The record links to 1 condition, with Actinic Keratosis appearing as the primary indexed condition, and to 3 interventions - of which Vehicle is the first listed.

NCT07144852 names 20 study sites across 15 states, led by Florida, South Carolina, Tennessee.

Frequently Asked Questions

What is clinical trial NCT07144852 about?

NCT07144852 is a clinical study titled "Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities". 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 upper extremities...

What is the current status of trial NCT07144852?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2025-11-29. Estimated completion is 2027-04.

What conditions does trial NCT07144852 study?

This clinical trial studies the following conditions: Actinic Keratosis.

What interventions are being tested in trial NCT07144852?

The interventions under investigation include: Vehicle (OTHER), Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% (DRUG), Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E. (DEVICE).

Who is sponsoring clinical trial NCT07144852?

This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07144852 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Actinic Keratosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07144852's enrollment target sits among peer trials

260 5th of 16 higher than 12 of 16 other Actinic Keratosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Actinic Keratosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT07144852, the US trial registry maintained by the National Library of Medicine. NCT07144852 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.