Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472459
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2007-05-10
Brief Title:
PDT With Metvix 160 mgg Cream in Organ Transplant Recipients With Non-melanoma Skin Cancer
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multicentre Randomised Study of Photodynamic TherapyPDT With Metvix 160 mgg Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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:
Patients on immunosuppressive therapy eg organ recipients have a higher occurrence of AK than the untreated population Keratotic lesions ie AK lesions and warts in this population is highly associated with development of SCC also with 10 times higher mortality rate because of SCC than expected The risk of developing skin cancer predominantly SCC and BCC increases with graft survival time and the length of immunosuppressive treatment period
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population indicate the need for early removal of these pre-malignant lesions
In this study two contralateral areas 5x10 cm2 with skin lesions within the patient will be compared One area will receive Metvix PDT at defined intervals and the other will receive lesion specific treatment at the discretion of the investigator The primary end-point will be the accumulated number of new lesions during the study and number of AK lesions that show complete response 3 months after baseline Secondary endpoints will be number of BCC lesions that show complete response number of recurrent lesions assessment of cosmetic outcome and safety
The higher risk of developing skin malignancy and more aggressive skin malignancies in this population indicate the need for early removal of these pre-malignant lesions
In this study two contralateral areas 5x10 cm2 with skin lesions within the patient will be compared One area will receive Metvix PDT at defined intervals and the other will receive lesion specific treatment at the discretion of the investigator The primary end-point will be the accumulated number of new lesions during the study and number of AK lesions that show complete response 3 months after baseline Secondary endpoints will be number of BCC lesions that show complete response number of recurrent lesions assessment of cosmetic outcome and safety
Detailed Description:
The treatment area 5x10 cm2 will be treated at baseline and at 3 9 and 15 months visits At baseline the area will be treated with fractionated Metvix PDT treatment consisting of two treatment one week apart and at 3 9 and 15 months visits with single Metvix PDT treatment The patients will be evaluated for occurrence of new lesions lesion response and recurrence at 3 not recurrence 9 15 21 and 27 months visits New and recurrent lesions in the treated area will be treated with Metvix PDT treatment Lesions with partial response in the treated area will be re-treated with Metvix PDT and lesions with no response will be treated with lesion specific treatment at the discretion of the investigator
In the contralateral control area 5x10 cm2 new and recurrent lesions and lesions in non-complete response will be treated with lesion specific treatment at the discretion of the investigator at each study visit
In the contralateral control area 5x10 cm2 new and recurrent lesions and lesions in non-complete response will be treated with lesion specific treatment at the discretion of the investigator at each study visit
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