Actively Recruiting
Randomized, Multi-Center, Evaluator-Blind Study of Reformulated Levulan Kerastick Plus Photodynamic Therapy for Treating Actinic Keratosis on the Face and Bald Scalp
Led by Sun Pharmaceutical Industries, Inc. · Updated on 2026-04-22
160
Participants Needed
10
Research Sites
12 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for treating actinic keratosis (AK) lesions on the face or bald scalp. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 160 adult patients having 4 to 8 mild to moderate AK lesions. The study aims to compare different treatment approaches and incubation times to understand their effects on AK clearance and patient satisfaction. Participants will be assigned to one of four groups based on treatment type—either the active drug Levulan or a vehicle without active ingredient—and one of two incubation times before blue light therapy is applied. Up to two PDT sessions may be given depending on how the lesions respond. The study includes both drug and device interventions, specifically topical solutions and a blue light PDT device. During the study, participants will undergo multiple assessments including evaluations of lesion clearance, changes in lesion count and size, cosmetic response, and patient satisfaction at various time points up to 24 weeks. Safety will be monitored through adverse event reporting, skin reaction assessments, vital signs, and laboratory tests. The main outcome measure is the complete clearance rate of AK lesions at 12 weeks. Participants will be followed closely to assess treatment effects and safety over the study period.
CONDITIONS
Brief Title
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 85 years
- Have 4 to 8 mild to moderate actinic keratosis lesions (Olsen grade 1 or 2) in a single treatment area on the face or bald scalp
- Each lesion is 1 cm or smaller in diameter and spaced at least 1 cm apart
- Overall treatment area is about 25 cm², excluding sensitive facial areas
- In good general health and able to avoid sunbathing or tanning devices during the study
- Willing to stop using all topical products in the treatment area within 8 hours of efficacy 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 or untreated/suspicious skin cancers in the treatment area
- Significant skin conditions like psoriasis or eczema in the treatment area
- Active herpes simplex infection or history of 2 or more outbreaks in the past year in the treatment area
- History of photosensitivity disorders or hypersensitivity to porphyrins
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C virus
- Immunosuppression or known blood clotting defects
- Use of certain topical therapies on the treatment area within 2 days to 8 weeks before randomization
- Use of systemic therapies like corticosteroids or immune modulators within 6 weeks to 6 months before randomization
- Use of phototoxic or photoallergic medications within 8 weeks of randomization
- Clinically significant or unstable illnesses or recent alcohol/drug abuse
- Pregnancy, breastfeeding, participation in another clinical study, or any condition the investigator deems unsuitable
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 - Up to 12 weeks
Participants receive topical application of Levulan Kerastick or Vehicle solution followed by blue light photodynamic therapy on the face or bald scalp.
Visits at Weeks 0, 4, 8, and 12 for treatment and assessments
Duration - Up to 12 weeks after treatment ends
Participants are monitored for treatment effectiveness, cosmetic response, and recurrence of actinic keratosis lesions.
Visits at Weeks 20 and 24 for follow-up assessments
Trial Site Locations
Total: 10 locations
1
Center for Dermatology Clinical Research, Inc
Fremont, California, United States, 94538
Actively Recruiting
2
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Actively Recruiting
3
Arlington Dermatology
Rolling Meadows, Illinois, United States, 60008
Actively Recruiting
4
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
Actively Recruiting
5
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
Actively Recruiting
6
Medisearch, LLC
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
7
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
Actively Recruiting
8
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States, 29615
Actively Recruiting
9
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Actively Recruiting
10
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
4
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