Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Clinical response (Size of the lesion. RECIST criteria. Complete Response (CR); Partial Response (PR); Stable Disease (SD) and Progression Disease (PD)). Measuring time: at baseline and at week 16 after starting the treatment. Dermatocopy (Characteristics of lesions by dermatoscopic imagines. The response will be declared as: absence of tumor cells or presence of tumor cells). Measuring time: at baseline and at week 16. Histology (Histological characteristics of lesions. Will be classified in the following categories: Absence of tumor: Without histological evidence of neoplastic cells; Presence of tumor: Histological evidence of neoplastic cells). Measuring time: at baseline and at week 16.
Key secondary outcomes:
Clinical response time (Time to reach partial or complete response). Measuring time: weeks 1, 4, 8, 12 and 16. Quality of scarring; Will be evaluated since the clinical standpoint, in patients that respond completely to treatment. Measuring time: at a week 16 and anually for 10 years. Time to recurrence (Time elapsing from the first day provided the absence of neoplasic cells according to the evaluation histological or clinical (patient refusal to biopsy end or biopsy no useful), until appears an injury histologically demonstrated in the treated site). Measuring time: anually for 10 years. Presence of clinical adverse events (AE) (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time between beginning and end of the event), intensity of AE (mild, moderate, severe), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: during whole treatment. Anti-IFN alpha and gamma antibodies (Patients that develop antibodies (Yes, No) determined by ELISA technique). Measuring time: at baseline and after treatment.