New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

Norwegian University of Science and Technology

Status: Completed

Conditions: Carcinoma, Basal Cell; Skin Neoplasms

Treatments: Drug: usual MAL-PDT; Drug: MAL-PDT re-treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01482104

EC-004

2011-004797-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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277 participants in 2 patient groups

MAL-PDT re-treatment

Experimental group

Description:

1 treatment of MAL-PDT with re-treatment of non-complete responders

Treatment:

Drug: MAL-PDT re-treatment

usual MAL-PDT

Active Comparator group

Description:

2 MAL-PDT treatments 1 week apart

Treatment:

Drug: usual MAL-PDT