Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473343
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2007-05-14
Brief Title:
Metvix PDT in Participant With High Risk Basal Cell Carcinoma
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
An Open Multicenter Phase III Study of Photodynamic Therapy With Metvix Cream 160 mgg in Patients With High Risk Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-06
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 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 there has been an increasing interest in using precursors of the endogenous photoactive porphyrins The most commonly used precursors have been 5-aminolevulinic acid ALA and its derivatives The present test drug Metvix contains the methyl ester of ALA which penetrates the lesions well and shows high lesion selectivity
BCC is a highly frequent skin malignancy and accounts for approximately 75 of all non-melanoma skin cancers It is the most common cancer in humans Several non-pharmacological treatment modalities are used for BCC including excision surgery curettage and electrodesiccation cryosurgery and more advanced modalities like radiation therapy plastic surgery with reconstruction and Mohs surgery The treatment used depends on the type size depth and localisation of the BCC lesion Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as high-risk BCC
In this particular participant group even a moderate complete response rate with good cosmetic results may be considered beneficial since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery In the case of treatment failure Metvix PDT does not interfere with the use of other treatment modalities
The variable complete response after one or two Metvix treatment cycles was used as the basis for the justification of sample size
For skin diseases there has been an increasing interest in using precursors of the endogenous photoactive porphyrins The most commonly used precursors have been 5-aminolevulinic acid ALA and its derivatives The present test drug Metvix contains the methyl ester of ALA which penetrates the lesions well and shows high lesion selectivity
BCC is a highly frequent skin malignancy and accounts for approximately 75 of all non-melanoma skin cancers It is the most common cancer in humans Several non-pharmacological treatment modalities are used for BCC including excision surgery curettage and electrodesiccation cryosurgery and more advanced modalities like radiation therapy plastic surgery with reconstruction and Mohs surgery The treatment used depends on the type size depth and localisation of the BCC lesion Treatment options for BCC give good response rates in the majority of participants but are inadequate in a small group of participants defined as high-risk BCC
In this particular participant group even a moderate complete response rate with good cosmetic results may be considered beneficial since the number of participant who have to receive more advanced therapy with the possibility of high morbidity and poor cosmetic outcome was reduced Even a partial response is of clinical interest since the remaining tumour was require less extensive surgery In the case of treatment failure Metvix PDT does not interfere with the use of other treatment modalities
The variable complete response after one or two Metvix treatment cycles was used as the basis for the justification of sample size
Detailed Description:
Prospective open multicenter study The high risk BCC lesions were treated with Metvix cream A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apart Lesions that did not respond completely after three months received a second PDT treatment cycle
The primary end-point was the histologically confirmed complete response rate within a participant No BCC cells in the biopsy taken 3 months after the last treatment
The primary end-point was the histologically confirmed complete response rate within a participant No BCC cells in the biopsy taken 3 months after the last treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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