NCT00926952

Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Innovaderm Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Methylaminolevulinate (Metvix, Metvixia)	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	Photodynamic Therapy (Aktilite)	Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-06-24
• Last updated: 2011-09-09
• Results posted: 2011-02-17

Locations

1 site across 1 country: Canada