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

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ClinicalTrials.gov Identifier: NCT01482104
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Skin Neoplasms Carcinoma, Basal Cell Drug: MAL-PDT re-treatment Drug: usual MAL-PDT

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 2012
Primary Completion Date : October 2017
Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Methyl-aminolevulinate

Outcome Measures

Primary Outcome Measures :
  1. lesions response rate [ Time Frame: 3 years ]
    Number of lesions in clinical complete response at follow-up

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482104

Dept Dermatology, Haukeland University Hospital
Bergen, Norway
Central Hospital Førde
Førde, Norway
Hudlegekontoret Lillehammer AS
Lillehammer, Norway
Akerskus Dermatological Centre
Lørenskog, Norway
Dept Dermatology, Oslo University Hospital
Oslo, Norway
Dept Surgery, Oslo University Hospital
Oslo, Norway
Hudlegen på Holtet
Oslo, Norway
Dept Dermato-Venereology, Stavanger University Hospital
Stavanger, Norway
Department of Cancer Research and Molecular Medicine, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Akershus Dermatological Centre
Helse Stavanger HF
Oslo University Hospital
Førde Central Hospital
Haukeland University Hospital
Hudlegekontoret Lillehammer
Hudlegene på Holtet DA
Study Director: Magne Børset, PhD prof Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01482104     History of Changes
Other Study ID Numbers: EC-004
2011-004797-28 ( EudraCT Number )
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
methyl 5-aminolevulinate

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents