Actinic Keratosis Clinical Trial
Official title:
Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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