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
Day 0.
Interventional
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
12 weeks
No
Robert Bissonnette, MD, FRCPC
Principal Investigator
Innovaderm Research
Canada: Health Canada
Inno-6010
NCT00926952
July 2009
January 2011
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