New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
NCT ID: NCT01482104
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
277 participants
INTERVENTIONAL
2012-06-30
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MAL-PDT re-treatment
1 treatment of MAL-PDT with re-treatment of non-complete responders
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
usual MAL-PDT
2 MAL-PDT treatments 1 week apart
usual MAL-PDT
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
usual MAL-PDT
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* written informed consent
* 1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akershus Dermatological Centre
UNKNOWN
Helse Stavanger HF
OTHER_GOV
Oslo University Hospital
OTHER
Førde Central Hospital
OTHER
Haukeland University Hospital
OTHER
Hudlegekontoret Lillehammer
UNKNOWN
Hudlegene på Holtet DA
UNKNOWN
Norwegian University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Magne Børset, PhD prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-004797-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EC-004
Identifier Type: -
Identifier Source: org_study_id