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New treatment option for Actinic Keratosis
Official title Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
ClinicalTrials.gov ID: NCT07144345
What this study is testing
What is Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%?
Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20% is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for actinic keratosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Patient is a male or non-pregnant female aged 18-85 years.
- 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...
- Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an how well it works...
- Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
You likely can't join if
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
- Use of specific topical therapies (e.g., retinoids, steroids, cryotherapy, PDT, chemical peels) on the treatment area within 2 days to 8 weeks prior...
See the full eligibility criteria
- Patient is a male or non-pregnant female aged 18-85 years.
- 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...
- Patients must be in good general health, avoid sunbathing or tanning devices, and maintain a consistent skincare routine throughout the study.
- Patient is willing to stop using all topical products within the Treatment Area within 8 hours of a scheduled clinic visit with an how well it works evaluation.
- Women of childbearing potential must use highly effective contraception; men with such partners must use barrier methods unless surgically sterile.
- Presence of Olsen grade 3 AK, untreated or suspicious skin cancers, or significant skin abnormalities (e.g., psoriasis, eczema) in the treatment area.
- Active herpes simplex infection or history of ≥2 outbreaks in the treatment area within the past year.
- History of cutaneous photosensitization, porphyria, photodermatosis, or hypersensitivity to porphyrins.
- Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
- Immunosuppressed status (e.g., HIV, organ transplant) or known coagulation defects.
- 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.
- Recent use of certain systemic therapies (e.g., corticosteroids, immune-modulators, retinoids, cytotoxic drugs) within 6 weeks to 6 months prior to randomization.
- Recent use of hypericin or other phototoxic/photoallergic medications (e.g., tetracyclines, psoralenes, St. John's wort) within 8 weeks of randomization.
- Clinically significant or unstable illnesses, or history of alcohol/drug abuse in the past year.
- Pregnancy/lactation, recent or current participation in another clinical study, or any other condition deemed unsuitable by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Fremont, California, United States
- Aventura, Florida, United States
- Rolling Meadows, Illinois, United States
- Plainfield, Indiana, United States
- New Brighton, Minnesota, United States
- Saint Joseph, Missouri, United States
- Portland, Oregon, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fremont, California, United States; Aventura, Florida, United States; Rolling Meadows, Illinois, United States; Plainfield, Indiana, United States; New Brighton, Minnesota, United States; Saint Joseph, Missouri, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.