Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Public ClinicalTrials.gov record NCT07144345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07144345
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2025
- Primary completion
- Dec 31, 2026
- Completion
- Mar 31, 2027
- Last update posted
- Apr 21, 2026
2025 – 2027
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Dermatology Clinical Research, Inc | Fremont | California | 94538 | Recruiting |
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | Recruiting |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | Recruiting |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | Recruiting |
| Minnesota Clinical Study Center | New Brighton | Minnesota | 55112 | Recruiting |
| Medisearch, LLC | Saint Joseph | Missouri | 64506 | Recruiting |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | Recruiting |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29615 | Recruiting |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | Recruiting |
| Premier Clinical Research | Spokane | Washington | 99202 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07144345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07144345 live on ClinicalTrials.gov.