Metvix Photodynamic Therapy (PDT) Versus Cryotherapy in Participants With Primary Superficial Basal Cell Carcinoma

Inclusion Criteria:

A participant with superficial BCC lesion(s) suitable for entry was defined as a participant 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), onlyparticipant above 19 years of age were to be included in Austria.

Exclusion Criteria:

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

• prior treatment of the BCC lesion(s)

• participant 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

• participant with porphyria

• participant with Gorlin's syndrome

• pigmented superficial BCC lesion(s)

• morpheaform lesion(s)

• infiltrating lesion(s)

• participants 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 30days

• pregnant or breast-feeding; all women of child-bearing potential had to document anegative pregnancy test and use the pill or intrauterine device during thetreatments 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.