An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities … (NCT07729579) | Clinical Trial Compass
RecruitingPhase 1
An Open-Label Pharmacokinetic Study for Patients With Actinic Keratosis on the Upper Extremities or the Face
United States48 participantsStarted 2026-08-04
Plain-language summary
The research study will evaluate how the body absorbs and reacts to reformulated Levulan Kerastick when applied to actinic keratosis lesions (AKs) on the skin of the forearms or face followed by photodynamic therapy (PDT), a treatment that uses application of blue light.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provided written Informed Consent.
* Patient is willing and able to comply with study protocol, visit schedule, and other study-related instructions/procedures, including in-clinic stay as required.
* Patient is a male or non-pregnant female 18 to 85 years of age (inclusive) at Screening.
* Patient has either 4 or more AK lesions on the upper extremities; or 6 or more AK lesions on the face. Lesions must be within an area of 25 cm2.
* Patient is in good general health and free of any disease state or physical condition.
* Patient has veins suitable for repeat blood draws.
* Patient is willing to abstain from sunbathing, solarium use, exposure to artificial tanning devices.
* Patient is willing to follow a consistent skin care routine without significant change.
* Patient is willing to stop using all topical products within the Treatment Area(s) starting from 8 hours prior to initiation of treatment.
* Patients who are women of childbearing potential must agree to use a highly effective method of contraception during the study.
* Patients who are male with female partners of childbearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile.
* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test before initiation of treatment at Baseline.
Exclusion Criteria:
* Patient is pregnant, lactating, or is planning to become pregnant during the study.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.