Field Actinic KeratosesNCT00535080
Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With Field Actinic Keratoses, Large/Multiple Superficial Basal Cell Carcinomas (BCCs), or Bowen's Disease
A study testing Metvix (methyl aminolevulinate) in people with Field Actinic Keratoses and Basal Cell Carcinoma, run by Galderma R&D.
Trial summary
The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Field Actinic Keratoses, Basal Cell Carcinoma, Bowen's Disease
- What is being tested?
- Metvix (methyl aminolevulinate)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Male or female subject older than 18 years.
- Subject presenting with:
- Either field actinic keratoses (AKs) (mild to moderate, multiple and clustered AKs on a severely sun-damaged skin); or
- Biopsy-confirmed large, or multiple (several in the same anatomical area) primary superficial BCC lesions that are macroscopically and histologically consistent with superficial basal cell carcinoma (sBCC) and have no histological evidence of aggressive growth patterns; or
- Histologically confirmed diagnosis of Bowen's disease from a biopsy taken within 3 months
- Any subject presenting with the aforementioned lesions must not be able to be treated optimally by conventional therapies.
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- Female subject of childbearing potential, using an effective birth control method (see Case Report Form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential
- Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
- Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
Who cannot join
- A recurrent superficial BCC lesion that has previously been treated.
- Subject whose lesions on the selected treatment zone (including a 5 cm margin around the treatment area) have been treated with any of the following topical treatments within the specified washout period:
- 5-FU - 3 months
- Cryotherapy - 3 months
- Imiquimod - 3 months
- PDT - 3 months
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- Diclofenac sodium - 3 months
- Surgery, radiotherapy, curettage, electrodesiccation, retinoids, dermabrasion, laser resurfacing, salicylic acid - 3 months
- A primary superficial BCC located close to or involving a scar of SCC
- Subject with known porphyria.
- Subject with target lesions on the genitals.
- Subject with known xeroderma pigmentosum.
- Pigmented lesion(s) on the treated area.
- Morpheaform lesion(s) on the treated area.
- Infiltrating lesion(s) on the treated area.
- Female subject who is pregnant, nursing or planning a pregnancy during the study.
- Subject with known hypersensitivity to methyl 5-aminolevulinate, a similar compound or excipients of the cream.
- Subject who has participated in another investigational drug or device research study within 30 days of enrolment.
About this study
Official title: Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease
The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.
- Being tested
- Metvix (methyl aminolevulinate)
- Keywords
- actinic, keratoses, superficial, basal, carcinomas, Bowen's, large or multiple superficial Basal Carcinomas
- Medical subject headings
- Carcinoma, Basal Cell, Bowen's Disease, Keratosis, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metvix (methyl aminolevulinate)Drug
Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm².
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Field Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535080
- Sponsor's protocol ID
- CAN.15.SPR.001
- Status last verified
- Oct 2009
- First submitted
- 21 Sep 2007
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease
- ClinicalTrials.gov ID
- NCT00535080
- Acronym / sponsor ID
- CAN.15.SPR.001
- Keywords
- actinic, keratoses, superficial, basal, carcinomas, Bowen's, large or multiple superficial Basal Carcinomas
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- First posted
- 26 Sep 2007 (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.
The aim of this study is to provide this investigational drug to patients who cannot be optimally treated with conventional therapies and to collect efficacy and safety data on the use of Metvix PDT in subjects with field actinic keratoses, large/multiple superficial basal cell carcinomas (BCCs) or Bowen's disease.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject older than 18 years.
- Subject presenting with:
- Any subject presenting with the aforementioned lesions must not be able to be treated optimally by conventional therapies.
- Female subject of childbearing potential, using an effective birth control method (see Case Report Form) and having a negative pregnancy test at the beginning of the study, or female subject of non childbearing potential
- Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
Key exclusion criteria (18 listed)
- A recurrent superficial BCC lesion that has previously been treated.
- Subject whose lesions on the selected treatment zone (including a 5 cm margin around the treatment area) have been treated with any of the following topical treatments within the specified washout period:
- A primary superficial BCC located close to or involving a scar of SCC
- Subject with known porphyria.
- Subject with target lesions on the genitals.
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 |
|---|---|---|
| Metvix (methyl aminolevulinate)Metvix (methyl aminolevulinate) (MAL), Photodynamic Therapy (PDT), cream, 160 mg/g. MAL cream will be applied for 3 hours then will be removed. The target area will then be exposed to red light (using a large-field LED light source: Aktilite 128) for 7 to 10 minutes at a dosage of 37 J/cm². | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Metvix (methyl aminolevulinate) in people with Field Actinic Keratoses and Basal Cell Carcinoma, run by Galderma R&D.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 18 Feb 2021.