NCT00304239

Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp

A Multicenter, Double Blind, Vehicle-controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the Light-emitting diode (LED) light source Aktilite CL128, in treatment of participants with multiple actinic keratosis (sun-damaged skin) on the face and/or scalp.

Detailed description

Actinic keratoses are pre-malignant skin lesions, which may develop to squamous cell carcinomas (SCC). They are usually small, thin, erythematous, de-squamating lesions on light exposed atrophic skin and the lesions are often multiple. Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination. For skin diseases, such as actinic keratosis (AK), there has been an increasing interest in using topically applied precursors of the photoactive porphyrins (PAP). The most commonly used precursors have been 5-aminolevulinic acid (ALA) and its derivatives. The present test drug contains methyl aminolevulinate, which penetrates the lesions well and shows high lesion selectivity. Different light sources (i.e. CureLight, Aktilite CL16 and Aktilite CL128) had been used for the activation of PAP, which absorbs light in the range of 400-700 nanometer (nm). The present study used the Aktilite CL 128 lamp. Aktilite 128 was based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study was similar to two other studies performed, on which the U.S. approval of Metvixia cream was based except for the light source used. This study was one of two studies performed to document the safety and efficacy of the Aktilite CL 128 lamp when used in combination with Metvixia cream. Previous studies have shown that the risks attributed to Metvixia PDT are few and related mainly to transient pain and local erythema during and shortly after treatment. These reactions are part of the expected local phototoxicity reaction. PDT offers an advantage to other treatment modalities for actinic keratosis, being a non-invasive treatment available on an outpatient basis. Several separate lesions can be treated simultaneously and the same lesion(s) can be treated repeatedly with success. There are no known systemic toxicity or interaction with other medication. The treatment is also lesion selective, leaving the surrounding tissue intact and functional, also allowing excellent cosmetic results after treatment.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Metvix-PDT	Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.
COMBINATION_PRODUCT	Vehicle-PDT	Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.

Timeline

• Start date: 2006-03-13
• Primary completion: 2007-01-23
• Completion: 2007-01-23
• First posted: 2006-03-17
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

11 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study