An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Patients With "High Risk" Basal Cell Carcinoma
Prospective, open, multicenter study. The high risk BCC lesions will be treated with Metvix
cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6
months prior to treatment. The patients will receive one or two treatment cycles each
consisting of two Metvix PDT treatments 7 days apart (Lesion that show non-complete response
at 3 months will have a second PDT treatment cycle).
The primary end-point will be the histologically confirmed complete response rate within a
patient (No BCC cells in the biopsy taken 3 months after the last treatment).
Secondary endpoints are safety evaluation during the first 13 weeks or 6 months (if two
treatment cycles) after the first Metvix treatment, cosmetic outcome and recurrence rates
12, 24, 35, 48 and 60 months after the first Metvix treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end-point will be the histologically confirmed complete response rate within a patient (No BCC cells in the biopsy taken 3 months after the last treatment).
3 months after last treatment
Carl Vinciullo, MD
Dermatology Surgery & Laser Centre, Perth
Australia: Department of Health and Ageing Therapeutic Goods Administration