A Multicentre, 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.
A patient will be randomised to PDT with Metvix® cream or PDT with placebo cream. All
eligible BCC lesions within a patient will get the same treatment. All patients will get two
consecutive treatments one week apart. At the 3-months follow-up visit, lesions with no
clinical response or progression will be surgically excised. Lesions with partial response
(50% or greater reduction on lesion area) will be re-treated, if they do not show complete
response three months later they will be surgical excised. Lesions with complete response
will be surgically excised 6 months after the first or second PDT cycle. All excised tissue
specimens will be histological examined.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
The primary end-point will be the histologically confirmed complete response rate within a patient (100% of the BCC lesions must disappear completely).
6 months after last treatment
Peter Foley, MD
Department of Dermatology, St. Vincent's Hospital Melbourne
United States: Food and Drug Administration