A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell 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.

- Patients with BCC arising in a previous radiated area

- 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).