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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
Sponsor:
Collaborators:
Akershus Dermatological Centre
Helse Stavanger HF
Oslo University Hospital
Førde Central Hospital
Haukeland University Hospital
Hudlegekontoret Lillehammer
Hudlegene på Holtet DA
Information provided by (Responsible Party):
Norwegian University of Science and Technology

November 17, 2011
November 30, 2011
October 27, 2017
June 2012
October 2017   (Final data collection date for primary outcome measure)
lesions response rate [ Time Frame: 3 years ]
Number of lesions in clinical complete response at follow-up
Same as current
Complete list of historical versions of study NCT01482104 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • 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
  • Drug: usual MAL-PDT
    schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
    Other Name: Methyl-aminolevulinate
  • Experimental: MAL-PDT re-treatment
    1 treatment of MAL-PDT with re-treatment of non-complete responders
    Intervention: Drug: MAL-PDT re-treatment
  • Active Comparator: usual MAL-PDT
    2 MAL-PDT treatments 1 week apart
    Intervention: Drug: usual MAL-PDT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
Same as current
October 2017
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01482104
EC-004
2011-004797-28 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Norwegian University of Science and Technology
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
Norwegian University of Science and Technology
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP