Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Photosensitizing Agents

Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.

Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.

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.

Metvix-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.

Vehicle-PDT

Rolf M Szeimies, Professor

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.

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.

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

Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.

Lesion complete response rate was defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) after treatment. Percentage of lesions reported by location.

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with at least one treatment site adverse events were reported.

Galderma R&D

The safety population consisted of all participants for whom any kind of treatment was initiated.

Participants received Metvix-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.

Participant received Vehicle-PDT 160 mg/g cream on face and/or scalp for 3 hours on Day 0 and Day 7.

Participants received Vehicle-PDT on face and/or scalp for 3 hours on Day 0 and Day 7.

Total

Age, Continuous

Sex: Female, Male

Caucasian

Race/Ethnicity, Customized

Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.

Clinical Operations

Intention-to-treat (ITT) population consisted of all participants that were randomized and for whom any aspect of treatment with either Metvix-PDT or Vehicle-PDT was initiated.

Participant Complete Response Rate (CRR)

Face

Scalp

Lesion Complete Response Rate

Number of Participants With at Least One Treatment Site Adverse Events

Overall Study

Photodynamic therapy with methyl aminolevulinate cream

David Pariser, MD

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

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) have been used for the activation of PAP, which absorbs light in the range of 400-700 nm. The present study uses the Aktilite CL 128 lamp. Aktilite 128 is based on LED technology and emits a narrow red light spectrum with an average wavelength of 630 (+/-5) nm. This study is similar to two other studies performed, on which the U.S. approval of Metvixia® cream is based except for the light source used. This study is 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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp	NCT00304239	Actinic Keratos...	Metvix-PDT Vehicle-PDT	18 Years -	Galderma R&D
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp	NCT00304239	Actinic Keratos...	Metvix-PDT Vehicle-PDT	18 Years -	Galderma R&D
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp	NCT00306800	Actinic Keratos...	Photodynamic th...	18 Years -	Galderma R&D

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