A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Ca… (NCT05157763) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
United States32 participantsStarted 2021-06-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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,
What they're measuring
1
Incidence and severity of treatment-emergent AEs (TEAEs) and serious TEAEs (STEAEs).
Timeframe: Through study completion - an average of 16 weeks
2
Vital signs - proportion of patients with abnormal clinical significant measurements
Timeframe: Up to completion of treatment period - up to 5 weeks
3
Pain assessments- Proportion of patients with clinical significant elevation in NPRS score
Timeframe: Up to completion of treatment period - up to 5 weeks
4
Proportion of subjects discontinuing a treatment due to TEAEs, assessed over the entire course of the treatment.
Timeframe: Up to completion of treatment period - up to 5 weeks
5
Proportion of subjects that requested to discontinue the treatment
Timeframe: Up to completion of treatment period - up to 5 weeks
✕. 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,