Actively Recruiting
Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy for Actinic Keratosis on Upper Extremities
Led by Sun Pharmaceutical Industries, Inc. · Updated on 2026-04-22
260
Participants Needed
20
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of a reformulated Levulan Kerastick solution containing aminolevulinic acid hydrochloride (ALA HCl) 20%, combined with photodynamic therapy (PDT), for treating actinic keratosis (AK) lesions on the upper extremities. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study focuses on adults with 4-8 mild to moderate AK lesions on one arm. The study aims to assess complete clearance of AK lesions and other related outcomes including partial clearance, lesion count changes, recurrence, cosmetic response, and patient satisfaction. Participants will be randomly assigned to receive either the active treatment with reformulated Levulan Kerastick plus blue light PDT or a vehicle solution plus blue light PDT. Treatment involves applying the solution with occlusion and incubation followed by exposure to blue light using the BLU-U4170E device. Up to two PDT sessions may be administered depending on lesion clearance. The study includes a control group receiving the vehicle solution to compare outcomes. During the study, participants will undergo evaluations at multiple time points including weeks 4, 8, 12, 20, and 24 to assess lesion clearance, cosmetic response, and patient satisfaction. Safety monitoring includes checks for adverse events, local skin reactions, vital signs, and laboratory tests. The primary outcome, complete clearance rate, will be measured at week 12. The total study duration involves follow-up through week 24 to assess sustained effects and recurrence rates.
CONDITIONS
Brief Title
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 85 years
- 4 to 8 mild to moderate actinic keratosis lesions (Olsen grade 1 or 2) on one upper arm, each up to 1 cm in diameter and spaced at least 1 cm apart
- Treatment area approximately 25 cm² on the extensor surface of one upper extremity
- Good general health and able to avoid sunbathing or tanning devices
- Willing to stop using all topical products in the treatment area within 8 hours before clinic visits
- 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 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 or known coagulation defects
- Use of specific topical therapies (retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization
- Recent use of certain systemic therapies (corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization
- Recent use of phototoxic or photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization
- Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year
- Pregnancy or lactation, recent or current participation in another clinical study, or other conditions deemed unsuitable by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up assessments up to 24 weeks
Participants receive topical application of either the reformulated Levulan Kerastick or vehicle, followed by incubation with occlusion and subsequent blue light photodynamic therapy on the treatment area.
1 treatment visit and multiple follow-up visits at Weeks 4, 8, 12, 20, and 24
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
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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