A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma

Exclusion Criteria12

• Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,
• Other malignant cancers (non BCC) of the skin at the lesion's site,
• Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),
• Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,
• Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),
• History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
• Patients undergoing renal or peritoneal dialysis,
• Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition,
• Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,
• Current (within last 12 months) severe alcohol or drug use disorder
• Pregnant women (positive blood or urine pregnancy test) or nursing mothers,
• Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.