A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT.

Summary This is a Phase I study that will define the irradiance threshold for Metvix-PDT that causes no or minimal pain during treatment delivery, thus sparing patients the exposure to large amounts of analgesics and/or anesthesia.  Up to 2 lesions per treatment session can be accrued per patient.  Since it can be expected there exists dependence between responses obtained from the treatment of two lesions on the same patient, and because there are two different light delivery devices in use, the study is designed to have two arms, one for each device.  Patients will be randomized to either arm.  All patients will receive the same overall PDT dose.  It is the goal of this study to define the "low" irradiance that will cause no or minimal pain for the two light sources in use.  It is not the goal to determine whether one or the other light source is better or worse.