Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.
A total of 20 patients with at least 5 non-hypertrophic actinic keratoses (AK) of the face
were included in this open-label study. All AKs were mapped on a transparent template before
the first PDT treatment. At Day 0, all patients received methylaminolevulinate (MAL)
applied on the entire face (except the nose and peri-ocular area of 1-2 cm) without any skin
preparation. One to two 2 g MAL tubes was used for the entire face. MAL was applied
without occlusion. After a total of 90 +/- 5 minutes the skin was rinsed and exposed to 37
J/cm² of red light from an Aktilite™ device. Patients were seen at Week 4; if all facial AKs
did not show a complete response to treatment, the MAL-PDT procedure was repeated at Week 4.
Patients were seen again at Week 12 and 24.
The primary endpoint was at Week 12. Patients came back at Week 24 for a final safety
evaluation and to verify the recurrence of AK.
Efficacy is evaluated by assessing the mean number of facial AK at Week 12 as compared to
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean Number of Facial Actinic Keratoses at Week 12
Robert Bissonnette, MD, FRCPC
Canada: Health Canada