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- tangible and residual injury). Measuring time: at baseline and at week 16 after starting the treatment. Histological characteristics (Absence of tumor, Presence of tumor). Measuring time: at baseline and at week 16 after starting the treatment. Clinical response time(in weeks). Measuring time: Weeks 1, 2, 3 4, 6, 8, 10, 12, 14 and 16.
Key secondary outcomes:
Quality of scarring (Good, Regular or Bad). Measuring time: Will be evaluated since the clinical standpoint, in patients that respond completely to treatment, on the 16 week of having started the treatment and during follow-up, which will be three months during the 1st year, half in the 2nd and 3rd and annually in the 4th and 5th year. Scarring Good: • Color: normocromía, slight or slight hypochromia hyperchromia. • Volume: flat lesion, slight slight atrophy or hypertrophy. • Sensitivity: normal. Regular Scarring: • Color: moderate or moderate hypochromia hyperchromia • Volume: moderate moderate hypertrophy or atrophy. • Sensitivity: Light to moderate hyperesthesia, hypoesthesia, spontaneous pain or itching. Scarring Bad: • Color: hyperchromia severe, or severe hypochromia achromia. • Volume: severe hypertrophy, keloid or severe atrophy. • Sensitivity: Severe hyperesthesia, hypoesthesia, anesthesia, spontaneous pain or pruritus. Time to recurrence (Time elapsing from the first day provided the absence of neoplastic 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: Months 3, 6, 9, 12, 18, 24, 48, 60. Severe adverse events (Yes, No) Measuring time: At each dose during the 3 weeks of treatment. Anti-IFN alpha and gamma antibodies by ELISA (Patients that develop antibodies (Yes, No)). Measuring time: before treatment and on the 16 week of having started the treatment.