Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049959
Status:
TERMINATED
Last Update Posted:
2011-03-16
First Post:
2002-11-15
Brief Title:
Two Studies to Determine if Verteporfin PDT is Effective Safe in Treating Multiple Basal Cell Carcinoma of the Skin
Sponsor:
QLT Inc
Organization:
QLT Inc
Study Overview
Official Title:
A Randomized Placebo-Controlled Masked Multicenter Phase III Study Of Photodynamic Therapy With Verteporfin For Injection VFI For The Treatment Of Multiple Basal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug verteporfin in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors
Detailed Description:
Basal cell carcinoma BCC of the skin is the most common type of cancer that can be treated with various therapies including surgical removal A number of factors can lead to the development of multiple BCC of the skin including genetic disorders eg nevoid basal cell carcinoma syndrome Treatment of multiple BCC becomes much more challenging In these trials the experimental therapy verteporfin PDT is compared to placebo PDT PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin given intravenously and red light exposure of skin tumors
The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs Eligible subjects will have at least 3 BCCs Study subjects wont know which treatment they have been been assigned to - this is done randomly like flipping a coin After study treatment the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment Safety will be assessed by testing blood samples before and after study treatment and analyzing adverse events and skin reactions to the study treatment
The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs Eligible subjects will have at least 3 BCCs Study subjects wont know which treatment they have been been assigned to - this is done randomly like flipping a coin After study treatment the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment Safety will be assessed by testing blood samples before and after study treatment and analyzing adverse events and skin reactions to the study treatment
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