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

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 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.

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 (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 it's running

• 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
• Dermatologic Surgery Center of Washington
  Chevy Chase, Maryland, United States Recruiting
• Minnesota Clinical Study Center
  New Brighton, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Head, Regulatory Affairs
• Email: Clinical.Trial@sunpharma.com
• Phone: 9122 66455645

Similar studies

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

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

  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.

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

  This study is testing if using Imipramine with photodynamic therapy can help reduce pain for people getting treatment for actinic keratosis.

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• Multimodal Laser Treatment for Photodamaged Facial Skin

  A randomized split-face study tests a combination of three lasers and light therapy to improve sun-damaged facial skin and potentially help prevent skin cancer in adults with actinic keratosis.

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

  This study tests how the reformulated Levulan Kerastick behaves in the body when used on actinic keratosis lesions on the arms or face, followed by blue-light treatment.

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

  This study checks whether tirbanibulin used for facial actinic keratosis helps improve how the skin looks and feels over 57 days in adults already using the medicine.

  Recruiting at 2 sites Avant Health LLC · Manhattan Beach, California and 1 other locations · NCT07657988

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.