Conditions: Actinic Keratosis
Keywords: Actinic keratoses actinic keratosis methylamonolevulinate photodynamic therapy without occlusion short incubation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Patients had 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and waited 90 minutes prior to photodynamic therapy (PDT) using red light.

Interventions: intervention 1: Methylaminolevulinate (Metvix, Metvixia) intervention 2: Photodynamic Therapy (Aktilite)
Intervention descriptions: intervention 1: 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. intervention 2: Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Protocol document: