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

Recruiting now · Phase 1/Phase 2

Conditions studied: Superficial Basal Cell Carcinoma, Nodular Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05157763

Run by

MediWound Ltd

People needed

32

Starts

2021-06-30

Expected to finish

2022-06-01

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria- Patient level
• Male or female greater than age 18,
• 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.
• Lesion is present for no longer than 4 years.
• Lesion with a diameter of 5-10mm,
• 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.

You may not qualify if…

• Exclusion Criteria- Patient level
• 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.

Where it is running

• Center for Clinical and Cosmetic Research — Aventura, Florida, United States (enrolling)
• Center for Clinical Studies, LTD. LLP — Webster, Texas, United States (enrolling)
• Moore Clinical Research, Inc. — Brandon, Florida, United States

Full record on ClinicalTrials.gov

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