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

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.

Conditions

• Skin Neoplasms
• Carcinoma, Basal Cell

Interventions

DRUG

MAL-PDT re-treatment

a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months

DRUG

usual MAL-PDT

schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.

Sponsors & Collaborators

• Akershus Dermatological Centre

  collaborator UNKNOWN

• Helse Stavanger HF

  collaborator OTHER_GOV

• Oslo University Hospital

  collaborator OTHER

• Førde Central Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Hudlegekontoret Lillehammer

  collaborator UNKNOWN

• Hudlegene på Holtet DA

  collaborator UNKNOWN

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Magne Børset, PhD prof · Norwegian University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2017-10-31

Completion

2017-10-31

Countries

• Norway

Study Locations