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NCT07144345 · ClinicalTrials.gov registry record · Phase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
A Phase 3 study of Actinic Keratosis, sponsored by Sun Pharmaceutical Industries.
- Active
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 10
- Study locations
NCT07144345 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 160 participants, below the 179-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (11% lower). The trial reports 10 study locations across 10 states.
The verdict
NCT07144345, 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
- 160 participants
- Enrollment target
- 10
- 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 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
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-11-19 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (11% lower). 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 Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% is the first listed.
NCT07144345 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Illinois.
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.
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).
Who is sponsoring clinical trial NCT07144345?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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-
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Read our methodology - how this data is sourced, computed, and verified.
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