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Reformulated Levulan Kerastick plus blue‑light PDT for actinic keratoses on the upper arm

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 Upper Extremities

Phase 3 Interventional Sun Pharmaceutical Industries Limited · NCT07144852

This trial will test whether applying a reformulated Levulan Kerastick (aminolevulinic acid 20%) followed by blue‑light photodynamic therapy can clear 4–8 mild-to-moderate actinic keratoses on one upper arm in adults.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment260 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorSun Pharmaceutical Industries Limited Industry-sponsored
Locations20 sites (Phoenix, Arizona and 19 other locations)
Trial IDNCT07144852 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled trial enrolls approximately 260 adults with 4–8 mild to moderate actinic keratoses in a single 25 cm² area on one upper extremity. Participants are randomized to receive either reformulated Levulan Kerastick (ALA HCl 20%) or vehicle, each followed by exposure to a BLU-U blue‑light PDT illuminator, with up to two PDT sessions given depending on lesion clearance. The primary outcome is complete clearance rate at Week 12, with secondary endpoints including lesion-level clearance rates, 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 aged 18–85 in good general health who have 4–8 Olsen grade 1–2 actinic keratoses within a single ~25 cm² area on one upper extremity and who can attend in-person clinic visits and follow protocol restrictions (sun avoidance, stopping topical products as required).

Not a fit: Patients with Olsen grade 3 lesions, suspicious or untreated skin cancers, lesions outside the specified area, pregnant or breastfeeding individuals, or those unable to comply with visit or safety requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could increase clearance of multiple AK lesions across an upper-arm field and improve cosmetic outcomes with a topical, clinic-delivered procedure.

How similar studies have performed: Previous trials of topical aminolevulinic acid plus blue‑light PDT, including older Levulan formulations, have shown lesion clearance for AK, and this Phase 3 trial tests a reformulated product in that established treatment class.

Eligibility criteria

Show full inclusion / exclusion 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 on their Index arm, each measuring up to 1 cm in diameter and spaced at least 1 cm apart.

   \[The treatment area should be approximately 25 cm², located on the extensor surface of only one of the upper extremities that is selected as the Index arm\]
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

Phoenix, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Actinic KeratosisBlue Light Photodynamic Therapy, Skin Diseases, Precancerous Conditions, Photosensitizing Agents, Dermatologic Agents, Aminolevulinic Acid
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.