BridgeMD
Tests treatment safety and results for Superficial Basal Cell Carcinoma
Official title A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT05157763
What this study is testing
What is EscharEx 5% (EX-02 formulation)?
EscharEx 5% (EX-02 formulation) is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for superficial basal cell carcinoma.
Also referred to as EX-02 5%.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Lesion is present for no longer than 4 years.
- Lesion with a diameter of 5-10mm,
You likely can't join 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),
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aventura, Florida, United States
- Brandon, Florida, United States
- Webster, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aventura, Florida, United States; Brandon, Florida, United States; Webster, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.