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

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT01482104
Collaborator
Akershus Dermatological Centre (Other), Helse Stavanger HF (Other), Oslo University Hospital (Other), Førde Central Hospital (Other), Haukeland University Hospital (Other), Hudlegekontoret Lillehammer (Other), Hudlegene på Holtet DA (Other)
277
Enrollment
9
Locations
2
Arms
64
Actual Duration (Months)
30.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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 Phase
  • Drug: MAL-PDT re-treatment
  • Drug: usual MAL-PDT
 N/A

Study Design

Study Type:
Interventional
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 :
Jun 1, 2012
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Oct 1, 2017

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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. lesions response rate [3 years]

      Number of lesions in clinical complete response at follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Dept Dermatology, Haukeland University Hospital Bergen Norway
    2 Central Hospital Førde Førde Norway
    3 Hudlegekontoret Lillehammer AS Lillehammer Norway
    4 Akerskus Dermatological Centre Lørenskog Norway
    5 Dept Dermatology, Oslo University Hospital Oslo Norway
    6 Dept Surgery, Oslo University Hospital Oslo Norway
    7 Hudlegen på Holtet Oslo Norway
    8 Dept Dermato-Venereology, Stavanger University Hospital Stavanger Norway
    9 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

    Investigators

    • Study Director: Magne Børset, PhD prof, Norwegian University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT01482104
    Other Study ID Numbers:
    • EC-004
    • 2011-004797-28
    First Posted:
    Nov 30, 2011
    Last Update Posted:
    Oct 27, 2017
    Last Verified:
    Oct 1, 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
    Photochemotherapy
    methyl 5-aminolevulinate
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Basal Cell
    Skin Neoplasms
    Aminolevulinic Acid
    Methyl 5-aminolevulinate

    Study Results

    No Results Posted as of Oct 27, 2017