At a glance
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Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)
In Brief
A Phase 2 clinical trial evaluating Topical aminolevulinate (10% ALA gel) and Red light illumination for Actinic Keratosis. Completed, enrolled 30 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are: * Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance? * Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance? * Will the new test regimens achieve reduced pain during illumination? * Will the new test regimens be safe? Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.
Study Details
Timeline
Interventions
10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period
Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2