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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
1 treatment of MAL-PDT with re-treatment of non-complete responders
mal-pdt re-treatment Methyl-aminolevulinate
a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
(Active Comparator)
2 MAL-PDT treatments 1 week apart
usual mal-pdt Methyl-aminolevulinate
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.

Primary Outcomes

lesions response rate
time frame: 3 years

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.