Actively Recruiting
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Led by Sun Pharmaceutical Industries, Inc. · Updated on 2026-04-22
160
Participants Needed
10
Research Sites
71 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 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.
CONDITIONS
Official 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
- 4 to 8 mild to moderate actinic keratosis lesions in a single treatment area (face or bald scalp), each 1 cm or smaller and spaced at least 1 cm apart
- Treatment area approximately 25 cm², excluding sensitive facial regions
- Good general health and commitment to avoid sunbathing or tanning devices
- Willingness to stop using topical products within 8 hours of clinic visits for efficacy evaluation
- Women of childbearing potential must use effective contraception; men with such partners must use barrier methods unless surgically sterile
You will not qualify if you...
- Presence of severe (Olsen grade 3) actinic keratosis, untreated or suspicious skin cancers, or significant skin conditions (e.g., psoriasis, eczema) in the treatment area
- Active herpes simplex infection or history of two or more outbreaks in the treatment area within the past year
- History of photosensitization disorders or hypersensitivity to porphyrins
- Positive HIV, hepatitis B surface antigen, or hepatitis C virus test results
- Immunosuppressed status or known blood clotting defects
- Use of certain topical therapies (retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks before randomization
- Recent use of systemic therapies like corticosteroids, immune-modulators, retinoids, or cytotoxic drugs within 6 weeks to 6 months before randomization
- Use of phototoxic or photoallergic medications within 8 weeks before randomization
- Clinically significant or unstable illnesses, or history of alcohol or drug abuse in the past year
- Pregnancy, breastfeeding, recent or current participation in another clinical study, or any condition deemed unsuitable by the investigator
AI-Screening
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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
CONTACT
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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