Compassionate Use of Metvix® (Methyl Aminolevulinate) Photodynamic Therapy (PDT) in Subjects With… (NCT00535080) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
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
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* 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:
* 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
* Cry…