At a glance
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Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.
In Brief
A Phase 3 clinical trial evaluating Methylaminolevulinate (Metvix, Metvixia) and Photodynamic Therapy (Aktilite) for Actinic Keratosis. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.
Study Details
Timeline
Interventions
2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4.
Device set to 37 J/cm². Red light wavelength is approximately 630 nm.