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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2025-11-29 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07144852
The ClinicalTrials.gov registry entry for NCT07144852 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 173-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (50% higher). The listed sponsor is Sun Pharmaceutical Industries, which has 48 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
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