New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
Conditions
Skin Neoplasms - Carcinoma, Basal Cell
Conditions: official terms
Carcinoma - Carcinoma, Basal Cell - Skin Neoplasms
Conditions: Keywords
Photochemotherapy, methyl 5-aminolevulinate
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: MAL-PDT re-treatment Type: Drug
Name: usual MAL-PDT Type: Drug
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Dept Dermatology, Haukeland University Hospital
Bergen, Norway
Status: Recruiting
Contact: I Bachmann
Central Hospital Førde
Førde, Norway
Status: Recruiting
Contact: Ø Vatne
Hudlegekontoret Lillehammer AS
Lillehammer, Norway
Status: Recruiting
Contact: L K Dotterud
Akerskus Dermatological Centre
Lørenskog, Norway
Status: Recruiting
Contact: Cato Mørk, PhD
Dept Dermatology, Oslo University Hospital
Oslo, Norway
Status: Recruiting
Contact: P Helsing
Dept Surgery, Oslo University Hospital
Oslo, Norway
Status: Recruiting
Contact: T Warloe
Hudlegen på Holtet
Oslo, Norway
Status: Recruiting
Contact: A M Soler
Dept Dermato-Venereology, Stavanger University Hospital
Stavanger, Norway
Status: Recruiting
Contact: S Kroon
Department of Cancer Research and Molecular Medicine, NTNU
Trondheim, Norway
Status: Recruiting
Contact: Cato Mørk, PhD
Start Date
June 2012
Completion Date
June 2016
Sponsors
Norwegian University of Science and Technology
Source
Norwegian University of Science and Technology
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page