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
NCT ID: NCT00535080
Last Updated: 2021-02-18
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
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Galderma Canada
Related Links
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Related Info
Other Identifiers
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CAN.15.SPR.001
Identifier Type: -
Identifier Source: org_study_id
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