Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
This study is testing a reformulated version of Levulan Kerastick (aminolevulinic acid HCl 20%) combined with blue light Photodynamic Therapy (PDT) for treating actinic keratosis (AK) on the face or bald scalp. Researchers want to see how well this treatment works compared to a vehicle (a solution without the active ingredient). You may be eligible if you are an adult between 18 and 85 years old and have 4-8 mild to moderate AK lesions on your face or bald scalp. The main goal is to see how many patients achieve complete clearance of their AK lesions by Week 12. The current status of this study is unclear.
- Study design
- This is a Phase 3, randomized, multi-center study involving about 160 adult patients. It is evaluator-blind, meaning the people assessing your progress won't know which treatment you received, and it compares the active drug to a vehicle.
- What's involved
- You would be randomized into one of four treatment groups. You may receive up to two PDT sessions, depending on how your lesions clear.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be measured at Week 12 to see if your lesions have completely cleared.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
At a glance
Conditions
NCT07144345
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arlington Dermatology
Rolling Meadows, Illinoisno site contact published
Recruiting
Center for Clinical and Cosmetic Research
Aventura, Floridano site contact published
Recruiting
Center for Dermatology Clinical Research, Inc
Fremont, Californiano site contact published
Recruiting
Medisearch, LLC
Saint Joseph, Missourino site contact published
Recruiting
Minnesota Clinical Study Center
New Brighton, Minnesotano site contact published
Recruiting
Oregon Dermatology and Research Center
Portland, Oregonno site contact published
Recruiting
Palmetto Clinical Trial Services, LLC
Greenville, South Carolinano site contact published
Recruiting
Premier Clinical Research
Spokane, Washingtonno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Complete Clearance Rate (CCR) i.e., proportion of patients achieving complete clearance of all AK lesions in the Treatment Area.Week 12
Complete clearance is defined as clearance of all AK lesions in the Treatment Area after PDT 1 or PDT 2, if re-treated; lesions should no longer be palpable nor visible to be declared as "cleared".