Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Purpose
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.
Condition
- Actinic Keratosis
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient is a male or non-pregnant female aged 18-85 years. 2. Patient must have 4-8 mild to moderate actinic keratosis (AK) lesions (Olsen grade 1 or 2) in a single treatment area (either face or bald scalp, not both), each ≤1 cm in diameter and spaced at least 1 cm apart. [The treatment area should be approximately 25 cm², excluding sensitive facial regions (eyes, lips, nostrils, ears, mouth)] 3. Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study. 4. Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an efficacy evaluation. 5. Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
Exclusion Criteria
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area. 2. Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year. 3. History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins. 4. Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result 5. Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects. 6. Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior to randomization. 7. Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization. 8. Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization. 9. Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year. 10. Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- The participant, investigator and outcomes assessor are blinded to treatment assignment, as both Levulan and Vehicle products look identical and cannot be differentiated from the application characteristics.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Levulan + Incubation time 1 |
Levulan application + Incubation time 1 + blue light application |
|
|
Placebo Comparator Vehicle + Incubation time 1 |
Vehicle application + Incubation time 1 + blue light application |
|
|
Experimental Levulan + Incubation time 2 |
Levulan application + Incubation time 2 + blue light application |
|
|
Placebo Comparator Vehicle + Incubation time 2 |
Vehicle application + Incubation time 2 + blue light application |
|
Recruiting Locations
Center for Dermatology Clinical Research, Inc
Fremont, California 94538
Fremont, California 94538
Center for Clinical and Cosmetic Research
Aventura, Florida 33180
Aventura, Florida 33180
Arlington Dermatology
Rolling Meadows, Illinois 60008
Rolling Meadows, Illinois 60008
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
Plainfield, Indiana 46168
Minnesota Clinical Study Center
New Brighton, Minnesota 55112
New Brighton, Minnesota 55112
Medisearch, LLC
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Oregon Dermatology and Research Center
Portland, Oregon 97210
Portland, Oregon 97210
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Tennessee Clinical Research Center
Nashville, Tennessee 37215
Nashville, Tennessee 37215
Premier Clinical Research
Spokane, Washington 99202
Spokane, Washington 99202
More Details
- Status
- Recruiting
- Sponsor
- Sun Pharmaceutical Industries, Inc.