New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
This trial is active, not recruiting.
|Conditions||skin neoplasms, carcinoma, basal cell|
|Treatments||mal-pdt re-treatment, usual mal-pdt|
|Sponsor||Norwegian University of Science and Technology|
|Collaborator||Akershus Dermatological Centre|
|Start date||June 2012|
|End date||June 2017|
|Trial size||277 participants|
|Trial identifier||NCT01482104, 2011-004797-28, EC-004|
Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.
This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.
Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Bergen, Norway||Dept Dermatology, Haukeland University Hospital||no longer recruiting|
|Førde, Norway||Central Hospital Førde||no longer recruiting|
|Lillehammer, Norway||Hudlegekontoret Lillehammer AS||no longer recruiting|
|Lørenskog, Norway||Akerskus Dermatological Centre||no longer recruiting|
|Oslo, Norway||Dept Dermatology, Oslo University Hospital||no longer recruiting|
|Oslo, Norway||Dept Surgery, Oslo University Hospital||no longer recruiting|
|Oslo, Norway||Hudlegen på Holtet||no longer recruiting|
|Stavanger, Norway||Dept Dermato-Venereology, Stavanger University Hospital||no longer recruiting|
|Trondheim, Norway||Department of Cancer Research and Molecular Medicine, NTNU||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
lesions response rate
time frame: 3 years
Male or female participants at least 18 years old.
Inclusion Criteria: - male/female above 18 years of age - written informed consent - 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type Exclusion Criteria: - pregnancy - breastfeeding - Gorlin's syndrome - porphyria - xeroderma pigmentosum - history of arsenic exposure - known allergy to MAL - concomitant treatment with immunosuppressive medication - physical or mental conditions that most likely will prevent patients attending follow-up sessions
|Official title||A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma.|
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