Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304239
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2006-03-16
Brief Title:
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multicenter Double Blind Vehicle-controlled Randomized Study of Photodynamic Therapy PDT With Metvix 160 mgg Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face andor Scalp
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 ie 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 US 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 lesions 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
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 ie 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 US 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 lesions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-005015-13 | EUDRACT_NUMBER | None | None |