A Multicentre, Randomised Study of Photodynamic Therapy(PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer
The treatment area (5x10 cm2) will be treated at baseline and at 3, 9 and 15 months visits.
At baseline the area will be treated with fractionated Metvix® PDT treatment consisting of
two treatment one week apart and at 3, 9, and 15 months visits with single Metvix® PDT
treatment. The patients will be evaluated for occurrence of new lesions, lesion response and
recurrence at 3 (not recurrence), 9, 15, 21 and 27 months visits. New and recurrent lesions
in the treated area will be treated with Metvix® PDT treatment. Lesions with partial
response in the treated area will be re-treated with Metvix® PDT and lesions with no
response will be treated with lesion specific treatment at the discretion of the
In the contralateral control area (5x10 cm2), new and recurrent lesions and lesions in
non-complete response will be treated with lesion specific treatment at the discretion of
the investigator at each study visit.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
To Compare occurrence of new lesions (AK, BCC, SCC and warts) in the treated area with the contralateral control area (symmetrically).
3, 9, 15, 21 and 27 months after first treatment
Ann-Marie Wennberg, MD, PhD
Sahlgrenska University Hospital, Gothenburg, Sweden
Sweden: Medical Products Agency