EscharEx 5% (EX-02 formulation): EX-02 5% will be topically applied in a thick layer of 2-3 mm on the lesion surface for 8-12 hours including 5-10 mm margins and covered with an occlusive dressing. A new vial should be used for each application. Each patient will be treated with 7 applications.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs). — Through study completion - an average of 16 weeks All adverse events (AEs) will be listed. Adverse events records will include notification whether the AE is local and occurs near or in the target lesion. The AEs will be listed as counts and percentages by System Organ Class (SOC), Preferred Term (PT), severity, and time of onset. Serious Adverse Events will be analyzed in the same way as AEs
Vital signs - proportion of patients with abnormal clinical significant measurements — Up to completion of treatment period - up to 5 weeks Assessed pre 2nd, pre 5th application and post last application
Pain assessments- Proportion of patients with clinical significant elevation in NPRS score — Up to completion of treatment period - up to 5 weeks Assesed pre 2nd, pre 5th application and post last application compared with pre 1st application
Proportion of subjects discontinuing a treatment due to TEAEs, assessed over the entire course of the treatment. — Up to completion of treatment period - up to 5 weeks This proportion will be calculated, together with its 95% confidence interval based on the binomial distribution.
Proportion of subjects that requested to discontinue the treatment — Up to completion of treatment period - up to 5 weeks This will be assessed over the entire course of the treatment and will be calculated, together with its 95% confidence interval based on the binomial distribution
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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