Actively Recruiting
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Led by Sun Pharmaceutical Industries, Inc. · Updated on 2026-04-22
260
Participants Needed
20
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is a male or non-pregnant female aged 18-85 years
- Has 4-8 mild to moderate actinic keratosis lesions (Olsen grade 1 or 2) on one arm, each up to 1 cm, spaced at least 1 cm apart
- Treatment area is about 25 cm8 on the extensor surface of one upper arm
- In good general health and will avoid sunbathing or tanning devices during the study
- Will maintain a consistent skincare routine throughout the study
- Willing to stop using all topical products in the treatment area within 8 hours before clinic visits with efficacy evaluation
- Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile
You will not qualify if you...
- Presence of Olsen grade 3 actinic keratosis, untreated or suspicious skin cancers, or significant skin abnormalities like psoriasis or eczema in the treatment area
- Active herpes simplex infection or history of 2 or more outbreaks in the treatment area within the past year
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins
- Positive HIV test, hepatitis B surface antigen, or hepatitis C virus test
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects
- Use of specific topical therapies such as retinoids, steroids, cryotherapy, PDT, or chemical peels on the treatment area within 2 days to 8 weeks before randomization
- Recent use of certain systemic therapies including corticosteroids, immune-modulators, retinoids, or cytotoxic drugs within 6 weeks to 6 months before randomization
- Recent use of phototoxic or photoallergic medications like hypericin, tetracyclines, psoralenes, or St. John's wort within 8 weeks before randomization
- Clinically significant or unstable illnesses, or history of alcohol or drug abuse in the past year
- Pregnancy, lactation, recent or current participation in another clinical study, or any condition the investigator considers unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Medical Dermatology Specialist
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Center for Dermatology Clinical Research, Inc
Fremont, California, United States, 94538
Actively Recruiting
3
Clarity Dermatology, PLLC
Castle Rock, Colorado, United States, 80109
Actively Recruiting
4
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Actively Recruiting
5
Ziaderm Research LLC
North Miami Beach, Florida, United States, 33162
Actively Recruiting
6
Northwest Clinical Trials, Inc.
Boise, Idaho, United States, 83704
Actively Recruiting
7
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008
Actively Recruiting
8
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Actively Recruiting
9
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
10
Medisearch, LLC
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
11
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
12
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
13
Palmetto Clinical Trial Services, LLC
Anderson, South Carolina, United States, 29621
Actively Recruiting
14
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States, 29615
Actively Recruiting
15
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
16
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Actively Recruiting
17
J&S Studies, Inc
College Station, Texas, United States, 77845
Actively Recruiting
18
Pflugerville Dermatology Clinical Research Center, Inc. d/b/a Austin Institute for Clinical Research
Pflugerville, Texas, United States, 78660
Actively Recruiting
19
Dermatology of Seattle & Bellevue
Burien, Washington, United States, 98168
Actively Recruiting
20
Premier Clinical Research
Spokane, Washington, United States, 99202
Actively Recruiting
Research Team
H
Head, Regulatory Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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