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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical Dermatology Specialist
  Phoenix, Arizona, United States Recruiting
• Center for Dermatology Clinical Research, Inc
  Fremont, California, United States Recruiting
• Clarity Dermatology, PLLC
  Castle Rock, Colorado, United States Recruiting
• Center for Clinical and Cosmetic Research
  Aventura, Florida, United States Recruiting
• Ziaderm Research LLC
  North Miami Beach, Florida, United States Recruiting
• Northwest Clinical Trials, Inc.
  Boise, Idaho, United States Recruiting

Study contacts

• Study coordinator: Head, Regulatory Affairs
• Email: Clinical.Trial@sunpharma.com
• Phone: 0226645

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  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.

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• Using Imipramine to Reduce Pain from Photodynamic Therapy for Skin Lesions

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• Multimodal Laser Treatment for Photodamaged Facial Skin

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• Pharmacokinetic test of reformulated Levulan Kerastick for actinic keratosis on forearms or face

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• Tirbanibulin in adults with facial actinic keratosis: seeing if it improves appearance and skin feel

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.