Inclusion Criteria:

A patient with superficial BCC lesion(s) suitable for entry was defined as a patient with:

- histologically confirmed diagnosis of primary superficial BCC lesion(s)

- BCC lesions suitable for cryotherapy

- males or females above 18 years of age

- written informed consent. In accordance with Amendment 2 (local amendment), only
patients above 19 years of age were to be included in Austria.

Exclusion Criteria:

A patient or lesion fulfilling any of the following criteria was ineligible for inclusion:

- prior treatment of the BCC lesion(s)

- patients with more than 10 eligible BCC lesions

- a superficial BCC lesion with the largest diameter exceeding 15 mm on face/scalp,
larger than 20 mm on extremities and neck and larger than 30 mm on the trunk

- a superficial BCC lesion with the largest diameter smaller than 6 mm

- patient with porphyria

- patient with Gorlin's syndrome

- pigmented superficial BCC lesion(s)

- morpheaform lesion(s)

- infiltrating lesion(s)

- 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 had to document a
negative pregnancy test and use the pill or intrauterine device during the treatments
and for at least one month thereafter

- conditions associated with a risk of poor protocol compliance.

In Amendment 1 the following exclusion criteria were added:

- xeroderma pigmentosum lesion

- concurrent use of immunosuppressive medication.