Skin NeoplasmsNCT01482104
New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
A study testing MAL-PDT re-treatment and usual MAL-PDT in people with Skin Neoplasms and Carcinoma, Basal Cell, run by Norwegian University of Science and Technology at 9 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Neoplasms, Carcinoma, Basal Cell
- What is being tested?
- MAL-PDT re-treatment and usual MAL-PDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 9 sitesNorway
- Study dates
- Jun 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- breastfeeding
- Gorlin's syndrome
- porphyria
- xeroderma pigmentosum
- history of arsenic exposure
Show all 9Show fewer
- known allergy to MAL
- concomitant treatment with immunosuppressive medication
- physical or mental conditions that most likely will prevent patients attending follow-up sessions
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Dept Dermatology, Haukeland University Hospital
Bergen
Central Hospital Førde
Førde
Hudlegekontoret Lillehammer AS
Lillehammer
Akerskus Dermatological Centre
Lørenskog
Dept Dermatology, Oslo University Hospital
Oslo
Dept Surgery, Oslo University Hospital
Oslo
Hudlegen på Holtet
Oslo
Dept Dermato-Venereology, Stavanger University Hospital
Stavanger
Department of Cancer Research and Molecular Medicine, NTNU
Trondheim
About this study
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.
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.
- Conditions
- Skin Neoplasms, Carcinoma, Basal Cell
- Being tested
- MAL-PDT re-treatment, usual MAL-PDT
- Keywords
- Photochemotherapy, methyl 5-aminolevulinate
- Medical subject headings
- Skin Neoplasms, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAL-PDT re-treatmentDrug
Also called Methyl-aminolevulinate
a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
usual MAL-PDTDrug
Also called Methyl-aminolevulinate
schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
| Study group | Role | What they receive |
|---|---|---|
| MAL-PDT re-treatment | Experimental | 1 treatment of MAL-PDT with re-treatment of non-complete responders Receives: Drug: MAL-PDT re-treatment |
| usual MAL-PDT | Active comparator | 2 MAL-PDT treatments 1 week apart Receives: Drug: usual MAL-PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
lesions response rate
Number of lesions in clinical complete response at follow-up
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJun 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin NeoplasmsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Akershus Dermatological Centre, Helse Stavanger HF, Oslo University Hospital, Førde Central Hospital, Haukeland University Hospital, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA
- Responsible party
- Sponsor
- Investigators
- Magne Børset, PhD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482104
- Sponsor's protocol ID
- EC-004
- Other IDs
- 2011-004797-28
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2011
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01482104
- Acronym / sponsor ID
- EC-004
- Conditions
- Skin Neoplasms, Carcinoma, Basal Cell
- Keywords
- Photochemotherapy, methyl 5-aminolevulinate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Akershus Dermatological Centre, Helse Stavanger HF, Oslo University Hospital, Førde Central Hospital, Haukeland University Hospital, Hudlegekontoret Lillehammer, Hudlegene på Holtet DA
- Study start
- Jun 2012 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAL-PDT re-treatment | Experimental | Drug: MAL-PDT re-treatment1 treatment of MAL-PDT with re-treatment of non-complete responders |
| usual MAL-PDT | Active comparator | Drug: usual MAL-PDT2 MAL-PDT treatments 1 week apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- pregnancy
- breastfeeding
- Gorlin's syndrome
- porphyria
- xeroderma pigmentosum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAL-PDT re-treatmentAlso: Methyl-aminolevulinatea schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months | Drug | MAL-PDT re-treatment |
| usual MAL-PDTAlso: Methyl-aminolevulinateschedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart. | Drug | usual MAL-PDT |
Primary outcome
lesions response rate
Time frame: 3 years
Number of lesions in clinical complete response at follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magne Børset, PhD prof study director
Norwegian University of Science and Technology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAL-PDT re-treatment and usual MAL-PDT in people with Skin Neoplasms and Carcinoma, Basal Cell, run by Norwegian University of Science and Technology at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lesions response rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.