PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
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|ClinicalTrials.gov Identifier: NCT00472043|
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : September 3, 2010
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 photosensitiser protoporphyrin IX (PpIX). 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 .
In vitro studies of animal and human tissues have shown significant intracellular formation of photoactive porphyrins after addition of Metvix®. The increased levels of photoactive porphyrins induced cytotoxic effects in tumour cells after photoactivation.
The primary objective is to compare PDT with Metvix® cream to PDT with placebo cream in terms of patient complete response rates based on histologically verified disappearance of the lesions at 6 months after last treatment cycle.
Secondary objectives are to compare the two treatments in terms of histological and clinical mean patient response weighted by the number of lesions within a patient, lesion response rates across patients, clinical complete patient response, cosmetic outcome and adverse events.
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Procedure: PDT with Metvix 160 mg/g cream and Placebo cream||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma.|
|Study Start Date :||October 2000|
|Actual Study Completion Date :||September 2002|
- The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely). [ Time Frame: 6 months after last treatment ]
- Histological and clinical mean patient response rates weighted for the number of lesions within a patient [ Time Frame: 3 and 6 months after last treatment ]
- Histological and clinical number of lesions across patients that show complete response [ Time Frame: 3 and 6 months after last treatment ]
- Clinical complete patient response [ Time Frame: 3 and 6 months after last treatment ]
- Evaluation of cosmetic outcome [ Time Frame: 3 and 6 months after last treatment ]
- Adverse events [ Time Frame: 2 weeks, 4 weeks and 3 months after each treatment cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472043
|Australia, New South Wales|
|Dept. of Dermatology, Royal Prince Alfred Hospital|
|Camperdown, New South Wales, Australia, 2050|
|Dermatology Dept., St. George Hospital|
|Kogarah, New South Wales, Australia, 2217|
|Liverpool, New South Wales, Australia, 2170|
|Dr. Michael Freeman|
|Benowa, Queensland, Australia, 4217|
|Dermatology Dept., Princess Alexandra Hospital|
|Woolloongabba, Queensland, Australia|
|Department of Dermatology, St. Vincent's Hospital Melbourne|
|Fitzroy, Victoria, Australia, 3065|
|Australia, Western Australia|
|Fremantle, Western Australia, Australia, 6160|
|Principal Investigator:||Peter Foley, MD||Department of Dermatology, St. Vincent's Hospital Melbourne|