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

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.

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Basal Cell; Skin Neoplasms
• Intervention / Treatment: Drug: MAL-PDT re-treatment; Drug: usual MAL-PDT

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Dept Dermatology, Haukeland University Hospital
  • Førde, Norway
    • Central Hospital Førde
  • Lillehammer, Norway
    • Hudlegekontoret Lillehammer AS
  • Lørenskog, Norway
    • Akerskus Dermatological Centre
  • Oslo, Norway
    • Dept Dermatology, Oslo University Hospital
  • Oslo, Norway
    • Dept Surgery, Oslo University Hospital
  • Oslo, Norway
    • Hudlegen på Holtet
  • Stavanger, Norway
    • Dept Dermato-Venereology, Stavanger University Hospital
  • Trondheim, Norway
    • Department of Cancer Research and Molecular Medicine, NTNU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAL-PDT re-treatment; 1 treatment of MAL-PDT with re-treatment of non-complete responders	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; Other Names: Methyl-aminolevulinate
Active Comparator: usual MAL-PDT; 2 MAL-PDT treatments 1 week apart	Drug: usual MAL-PDT; schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.; Other Names: Methyl-aminolevulinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lesions response rate	Number of lesions in clinical complete response at follow-up	3 years

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; Helse Stavanger HF; Haukeland University Hospital; Førde Central Hospital; Akershus Dermatological Centre; Hudlegekontoret Lillehammer; Hudlegene på Holtet DA
• Investigators: Study Director: Magne Børset, PhD prof, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Photochemotherapy; methyl 5-aminolevulinate
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Skin Neoplasms; Carcinoma, Basal Cell; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid; Methyl 5-aminolevulinate
• Other Study ID Numbers: EC-004; 2011-004797-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No