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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2017

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.

Arms, Groups and Cohorts

  • Experimental: MAL-PDT re-treatment
    • 1 treatment of MAL-PDT with re-treatment of non-complete responders
  • Active Comparator: usual MAL-PDT
    • 2 MAL-PDT treatments 1 week apart

Clinical Trial Outcome Measures

Primary Measures

  • lesions response rate
    • Time Frame: 3 years
    • Number of lesions in clinical complete response at follow-up

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • Akershus Dermatological Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Magne Børset, PhD prof, Study Director, Norwegian University of Science and Technology

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