PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma

Inclusion Criteria:

A patient with primary, nodular BCC lesion(s) suitable for entry is defined as a patient with

• Clinically diagnosed primary nodular BCC lesion(s)
• Histologically confirmed diagnosis of BCC
• BCC lesions suitable for simple excision surgery.
• Males or females above 18 years of age.
• Written informed consent

Exclusion Criteria:

A patient that is ineligible for inclusion is a patient fulfilling any of the following criteria:

• Patient with porphyria.
• Patient with Gorlin's syndrome.
• Patient with Xeroderma pigmentosum
• Patients concurrently receiving immunosuppressive medication
• Patients with a history of arsenic exposure.
• Known allergy to Metvix®, a similar PDT compound or excipients of the cream
• Participation in other clinical studies either concurrently or within the last 30 days.
• Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (e.g. barrier methods, oral contraceptives or intrauterine device) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
• Conditions associated with a risk of poor protocol compliance.

Lesion Exclusion Criteria:

• A nodular BCC lesion in periorbital area, ears and nasolabial fold.
• A nodular BCC lesion with the longest diameter less than 6 mm or larger than 15 mm in face/scalp, larger than 20 mm on extremities and neck and larger than 30 mm on truncus.
• Pigmented nodular BCC lesion(s)
• Morpheaform nodular BCC lesion(s).
• Infiltrating nodular BCC lesion(s).
• Prior treatment of the BCC lesion(s).