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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a multicenter, prospective, open label, one-arm study intended to assess the Safety and Efficacy of EscharEx (EX-02) in the treatment of Basal Cell Carcinoma.

In patients with one primary superficial or nodular basal cell carcinoma lesion with a diameter of 5-10mm (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediWound Ltd

Criteria

Inclusion Criteria:

Inclusion Criteria- Patient level

1. Male or female greater than age 18,

2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.

3. Lesion is present for no longer than 4 years.

4. Lesion with a diameter of 5-10mm,

5. Patient and/or legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a written informed consent prior to any study procedure.

Exclusion Criteria:

Exclusion Criteria- Patient level

1. Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,

2. Other malignant cancers (non BCC) of the skin at the lesion's site,

3. Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),

4. Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,

5. Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),

6. 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,

7. Patients undergoing renal or peritoneal dialysis,

8. 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,

9. Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,

10. Current (within last 12 months) severe alcohol or drug use disorder

11. Pregnant women (positive blood or urine pregnancy test) or nursing mothers,

12. 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.