NCT05157763 · MediWound Ltd
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
What this study is about
This study will be a conducted at multiple hospitals, forward-looking, open label, one-treatment group$1 study intended to assess the Safety and effectiveness of EscharEx (EX-02) in the treatment of Basal Cell Carcinoma.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Aventura, Florida
- Brandon, Florida
- Webster, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 15, 2021 · Source of record for eligibility and locations