ZiaDerm Research is enrolling adults with actinic keratosis (AK) on the arms or hands for a clinical research study.
Actinic keratoses are common scaly or crusty skin growths that develop on areas of the body that receive frequent sun exposure. This study is evaluating the safety and effectiveness of an investigational reformulated Levulan Kerastick® used with photodynamic therapy (PDT), a treatment involving blue light.
Who May Be Considered for Screening?
You may be considered for screening if you:
- Are 18 to 85 years old
- Have actinic keratosis on one or both arms, hands, or forearms
- Have approximately 4 to 8 mild-to-moderate AK lesions in a treatment area on one arm
- Are willing and able to attend study visits and follow study instructions
A study doctor and research staff will review your health history, current medications, and AK lesions during screening to determine whether you may be able to participate. Completing screening does not guarantee eligibility or enrollment.
About the Study
If you qualify and choose to participate, you will be randomly assigned—like flipping a coin—to receive one of the following:
- Reformulated Levulan Kerastick plus PDT , or
- Vehicle plus PDT
The vehicle looks like the study treatment but does not contain the active ingredient. Participants have a 50% chance of receiving either study treatment.
The investigational treatment involves applying the study solution to a treatment area on one arm, followed by a three-hour incubation period and blue-light treatment for approximately 8 minutes and 20 seconds.
Time Commitment
Participation lasts about 6 months and may include up to 11 study visits, including the screening visit.
- Treatment visits occur at the beginning of the study and, if needed, around Week 8.
- Treatment visits may last approximately 4 hours .
- Follow-up visits take place through approximately Week 24.
Pls put a button: SEE IF YOU QUALIFY
About ZiaDerm Research
ZiaDerm Research is a clinical research center in North Miami Beach with experienced research staff and board-certified dermatologists. Participation in a clinical trial is voluntary, and participant safety is a priority throughout the study. To learn more or begin the screening process, contact ZiaDerm Research: