Reformulated Levulan Kerastick with blue light for actinic keratosis on the face or bald scalp

Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp

This Phase 3 trial will test whether reformulated Levulan Kerastick (aminolevulinic acid 20%) followed by blue light photodynamic therapy clears 4–8 mild-to-moderate actinic keratosis lesions in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sun Pharmaceutical Industries Limited (Industry-sponsored)
• Locations: 10 sites (Fremont, California and 9 other locations)
• Trial ID: NCT07144345 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter, evaluator-blind, vehicle-controlled Phase 3 trial will enroll about 160 adults with 4–8 mild-to-moderate actinic keratosis lesions on either the face or bald scalp and randomize them into four arms based on active drug versus vehicle and incubation time. Participants receive topical application of reformulated Levulan Kerastick (or vehicle) followed by blue light photodynamic therapy, with up to two PDT sessions depending on lesion clearance. The primary endpoint is complete clearance rate at Week 12, and secondary endpoints include lesion-level clearance, partial clearance, change in lesion count and area, recurrence, cosmetic response, and patient satisfaction. Safety monitoring includes adverse events, local skin reactions, vital signs, and laboratory tests.

Who should consider this trial

Good fit: Adults 18–85 in good general health with 4–8 mild-to-moderate (Olsen grade 1–2) actinic keratosis lesions confined to the face or bald scalp who can attend clinic visits and follow study precautions.

Not a fit: Patients with Olsen grade 3 lesions, suspicious or untreated skin cancers, lesions outside the defined treatment area, pregnant women, or those unable to attend in-person visits are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the regimen could increase clearance of AK lesions and improve cosmetic outcomes using a field-directed PDT approach.

How similar studies have performed: ALA-based photodynamic therapy has shown effectiveness for actinic keratosis in prior studies, and this trial tests a reformulated Levulan Kerastick and incubation-time strategy built on that established approach.

Eligibility criteria

Inclusion Criteria:

1. 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:

1. 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.

Where this trial is running

Fremont, California and 9 other locations

• Center for Dermatology Clinical Research, Inc — Fremont, California, United States (Recruiting)
• Center for Clinical and Cosmetic Research — Aventura, Florida, United States (Recruiting)
• Arlington Dermatology — Rolling Meadows, Illinois, United States (Recruiting)
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States (Recruiting)
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States (Recruiting)
• Medisearch, LLC — Saint Joseph, Missouri, United States (Recruiting)
• Oregon Dermatology and Research Center — Portland, Oregon, United States (Recruiting)
• Palmetto Clinical Trial Services, LLC — Greenville, South Carolina, United States (Recruiting)
• Tennessee Clinical Research Center — Nashville, Tennessee, United States (Recruiting)
• Premier Clinical Research — Spokane, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Head, Regulatory Affairs

Conditions Actinic Keratosis; Blue Light Photodynamic Therapy; Skin Diseases; Precancerous Conditions; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid