Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472108
Status:
COMPLETED
Last Update Posted:
2010-09-03
First Post:
2007-05-10
Brief Title:
Photodynamic Therapy PDT With Metvix Cream 160 mgg Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multicenter Phase III Double Blind Study of Photodynamic Therapy PDT With Metvix 160 mgg Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Photodynamic therapy PDT was the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen These cells accumulated more photosensitiser than normal cells The photosensitiser generated reactive oxygen species upon illumination
For skin diseases there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX PpIX The most commonly used precursors have been 5-aminolevulinic acid ALA and its derivatives The present test drug Metvix contained the methyl ester of ALA which penetrated the lesions well and shows high lesion selectivity
In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation
The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant lesion response rates across participants clinical complete participant response cosmetic outcome and adverse events
For skin diseases there had been an increasing interest in using precursors of the endogenous photosensitiser protoporphyrin IX PpIX The most commonly used precursors have been 5-aminolevulinic acid ALA and its derivatives The present test drug Metvix contained the methyl ester of ALA which penetrated the lesions well and shows high lesion selectivity
In vitro studies of animal and human tissues had shown significant intracellular formation of photoactive porphyrins after addition of Metvix The increased photoactive porphyrins levels induced cytotoxic effects in tumour cells after photoactivation
The primary objective was to compare PDT with Metvix cream to PDT with placebo cream in terms of participants complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle Secondary objectives was to compare the two treatments in terms of histological and clinical mean participant response weighted by the number of lesions within a participant lesion response rates across participants clinical complete participant response cosmetic outcome and adverse events
Detailed Description:
A participants were randomised to PDT with Metvix cream or PDT with placebo cream All eligible basal cell carcinoma BCC lesions within a participant received same treatment All participants received two consecutive treatments one week apart At the 3-months follow-up visit lesions with no clinical response or progression were surgically excised Lesions with partial response 50 percent or greater reduction on lesion area were re-treated if they do not show complete response three months later they were surgically excised Lesions with complete response were surgically excised 6 months after the first or second PDT cycle All excised tissue specimens were histologically examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None