Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease
- 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
- 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.
- 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
- 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.