Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469417
Status:
COMPLETED
Last Update Posted:
2010-09-03
First Post:
2007-05-03
Brief Title:
Metvix Photodynamic Therapy PDT Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multicenter Phase III Randomised Study of Photodynamic Therapy With Metvix Cream 160 mgg in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
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 methyl aminolevulinate MAL cream to cryotherapy in treatment of participants with primary superficial basal cell carcinoma BCC
Secondary objectives was to compare cosmetic outcome and tolerability adverse events in these participants 3 months after treatment In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment
Secondary objectives was to compare cosmetic outcome and tolerability adverse events in these participants 3 months after treatment In addition the recurrence rates in the two treatment groups will be compared up to five years after treatment
Detailed Description:
BCC was a highly frequent skin malignancy and accounts for approximately 75 of all non-melanoma skin cancers It is the most common malignant tumour of any organ mostly affecting head and neck 84 in fair-skinned people Several non-pharmacological treatment modalities was used for BCC including excision surgery Mohs surgery radiation curettageelectrodesiccation and cryotherapy The treatment used depends on the type size depth and localisation of the BCC lesion
The use of PDT was attractive for the treatment of BCCs because of its efficiency mild and local side effects and excellent cosmetic outcome Previous clinical experience was promising and participants with primary BCCs were included in this prospective randomised comparative multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome
The primary end-point is the number of participants in whom 75 or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy Both on-site and independent blinded response assessments analysed The analysis based on the results of the independent review board constitutes the primary analysis
The secondary end-points was the proportion of participants in whom less than 75 of the BCC lesions respond completely number of lesions across participants that show complete response evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy In addition 12 24 36 48 and 60 months recurrence rates was assessed
The use of PDT was attractive for the treatment of BCCs because of its efficiency mild and local side effects and excellent cosmetic outcome Previous clinical experience was promising and participants with primary BCCs were included in this prospective randomised comparative multicenter study to show that Metvix is non-inferior to alternative treatment with better cosmetic outcome
The primary end-point is the number of participants in whom 75 or more of the BCC lesions have responded completely at 3 months after PDT with Metvix or 3 months after cryotherapy Both on-site and independent blinded response assessments analysed The analysis based on the results of the independent review board constitutes the primary analysis
The secondary end-points was the proportion of participants in whom less than 75 of the BCC lesions respond completely number of lesions across participants that show complete response evaluation of cosmetic outcome and adverse events 3 months after Metvix PDT or 3 months after cryotherapy In addition 12 24 36 48 and 60 months recurrence rates was assessed
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