Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Actinic Keratosis, sponsored by Sun Pharmaceutical Industries.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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
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 |
What the registry record for NCT07144345 still lists
NCT07144345 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 16 other Actinic Keratosis trials with a reported enrollment target (11% lower).
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 lists 10 locations in 10 states (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
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 NCT07144345's enrollment target sits among peer trials
160 6th of 16 higher than 11 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
-
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
ACTIVE NOT RECRUITING · Phase 3
-
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
COMPLETED · Phase 3
-
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
COMPLETED · Phase 3
-
A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
COMPLETED · Phase 3
-
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
COMPLETED · Phase 3
-
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI